Novartis AG (NVS)
FDA Applications
Note: This list only includes applications that have been responded to by the FDA.
| Application | Product Name | Active Ingredient | Form | Strength | Status | ||
|---|---|---|---|---|---|---|---|
| BLA761349 - NOVARTIS PHARMS CORP | |||||||
| COSENTYX | SECUKINUMAB | INJECTABLE;INJECTION | 150MG | Prescription | |||
| BLA761128 - NOVARTIS PHARMS CORP | |||||||
| ADAKVEO | CRIZANLIZUMAB-TMCA | INJECTABLE; INJECTION | 100MG/10ML | Prescription | |||
| BLA761125 - NOVARTIS PHARMS CORP | |||||||
| BEOVU | brolucizumab-dbll | INJECTABLE; INTRAVITREAL | 6MG/0.05ML | Prescription | |||
| NDA218591 - NOVARTIS | |||||||
| ENTRESTO SPRINKLE | SACUBITRIL; VALSARTAN | CAPSULE, PELLETS;ORAL | 6MG;6MG | Prescription | |||
| ENTRESTO SPRINKLE | SACUBITRIL; VALSARTAN | CAPSULE, PELLETS;ORAL | 15MG;16MG | Prescription | |||
| NDA218466 - NOVARTIS | |||||||
| VIJOICE | ALPELISIB | GRANULES;ORAL | 50MG/PACKET | Prescription | |||
| NDA218276 - NOVARTIS | |||||||
| FABHALTA | IPTACOPAN HYDROCHLORIDE | CAPSULE;ORAL | EQ 200MG BASE | Prescription | |||
| NDA217514 - NOVARTIS | |||||||
| TAFINLAR | DABRAFENIB MESYLATE | TABLET, FOR SUSPENSION;ORAL | EQ 10MG BASE | Prescription | |||
| TAFINLAR | DABRAFENIB MESYLATE | CAPSULE;ORAL | 75MG | Prescription | |||
| TAFINLAR | DABRAFENIB MESYLATE | TABLET; ORAL SUSPENSION | 10MG | Prescription | |||
| NDA217513 - NOVARTIS | |||||||
| MEKINIST | TRAMETINIB DIMETHYL SULFOXIDE | SOLUTION;ORAL | EQ 0.05MG BASE/ML | Prescription | |||
| MEKINIST | TRAMETINIB | TABLET;ORAL | 2MG | Prescription | |||
| MEKINIST | TRAMETINIB | SOLUTION;ORAL | 4.7MG | Prescription | |||
| NDA215841 - NOVARTIS | |||||||
| LOCAMETZ | GALLIUM GA-68 GOZETOTIDE | POWDER;INTRAVENOUS | N/A | Prescription | |||
| NDA215833 - NOVARTIS | |||||||
| PLUVICTO | LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN | SOLUTION;INTRAVENOUS | 27mCi/ML | Prescription | |||
| NDA215358 - NOVARTIS | |||||||
| SCEMBLIX | ASCIMINIB HYDROCHLORIDE | TABLET;ORAL | EQ 20MG BASE | Prescription | |||
| SCEMBLIX | ASCIMINIB HYDROCHLORIDE | TABLET;ORAL | EQ 40MG BASE | Prescription | |||
| SCEMBLIX | ASCIMINIB HYDROCHLORIDE | TABLET;ORAL | EQ 100MG BASE | Prescription | |||
| NDA215039 - NOVARTIS | |||||||
| VIJOICE | ALPELISIB | TABLET;ORAL | 50MG | Prescription | |||
| VIJOICE | ALPELISIB | TABLET;ORAL | 125MG | Prescription | |||
| VIJOICE | ALPELISIB | TABLET;ORAL | 200MG | Prescription | |||
| NDA214012 - NOVARTIS | |||||||
| LEQVIO | INCLISIRAN SODIUM | SOLUTION;SUBCUTANEOUS | EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) | Prescription | |||
| NDA213591 - NOVARTIS PHARM | |||||||
| TABRECTA | CAPMATINIB HYDROCHLORIDE | TABLET;ORAL | EQ 150MG BASE | Prescription | |||
| TABRECTA | CAPMATINIB HYDROCHLORIDE | TABLET;ORAL | EQ 200MG BASE | Prescription | |||
| NDA212526 - NOVARTIS | |||||||
| PIQRAY | ALPELISIB | TABLET;ORAL | 50MG | Prescription | |||
| PIQRAY | ALPELISIB | TABLET;ORAL | 200MG | Prescription | |||
| PIQRAY | ALPELISIB | TABLET;ORAL | 150MG | Prescription | |||
| NDA211225 - NOVARTIS | |||||||
| ZYKADIA | CERITINIB | TABLET;ORAL | 150MG | Prescription | |||
| NDA209935 - NOVARTIS | |||||||
| KISQALI FEMARA CO-PACK (COPACKAGED) | LETROZOLE; RIBOCICLIB SUCCINATE | TABLET;ORAL | 2.5MG;EQ 200MG BASE | Prescription | |||
| NDA209884 - NOVARTIS | |||||||
| MAYZENT | SIPONIMOD | TABLET;ORAL | EQ 0.25MG BASE | Prescription | |||
| MAYZENT | SIPONIMOD | TABLET;ORAL | EQ 2MG BASE | Prescription | |||
| MAYZENT | SIPONIMOD | TABLET;ORAL | EQ 1MG BASE | Prescription | |||
| NDA209092 - NOVARTIS | |||||||
| KISQALI | RIBOCICLIB SUCCINATE | TABLET;ORAL | EQ 200MG BASE | Prescription | |||
| NDA208711 - NOVARTIS | |||||||
| EGATEN | TRICLABENDAZOLE | TABLET;ORAL | 250MG | Prescription | |||
| NDA207997 - NOVARTIS | |||||||
| RYDAPT | MIDOSTAURIN | CAPSULE;ORAL | 25MG | Prescription | |||
| NDA207968 - NOVARTIS | |||||||
| JADENU SPRINKLE | DEFERASIROX | GRANULE;ORAL | 360MG | Prescription | |||
| JADENU SPRINKLE | DEFERASIROX | GRANULE;ORAL | 180MG | Prescription | |||
| JADENU SPRINKLE | DEFERASIROX | GRANULE;ORAL | 90MG | Prescription | |||
| NDA207930 - NOVARTIS | |||||||
| UTIBRON | GLYCOPYRROLATE; INDACATEROL MALEATE | POWDER;INHALATION | 15.6MCG/INH;27.5MCG/INH | Discontinued | |||
| NDA207923 - NOVARTIS | |||||||
| SEEBRI | GLYCOPYRROLATE | POWDER;INHALATION | 15.6MCG/INH | Discontinued | |||
| NDA207620 - NOVARTIS PHARMS CORP | |||||||
| ENTRESTO | SACUBITRIL; VALSARTAN | TABLET;ORAL | 24MG;26MG | Prescription | |||
| ENTRESTO | SACUBITRIL; VALSARTAN | TABLET;ORAL | 97MG;103MG | Prescription | |||
| ENTRESTO | SACUBITRIL; VALSARTAN | TABLET;ORAL | 49MG;51MG | Prescription | |||
| NDA207027 - NOVARTIS | |||||||
| PROMACTA KIT | ELTROMBOPAG OLAMINE | FOR SUSPENSION;ORAL | EQ 25MG ACID/PACKET | Prescription | |||
| PROMACTA KIT | ELTROMBOPAG OLAMINE | FOR SUSPENSION;ORAL | EQ 12.5MG ACID/PACKET | Prescription | |||
| NDA206910 - NOVARTIS PHARMS CORP | |||||||
| JADENU | DEFERASIROX | TABLET;ORAL | 360MG | Prescription | |||
| JADENU | DEFERASIROX | TABLET;ORAL | 180MG | Prescription | |||
| JADENU | DEFERASIROX | TABLET;ORAL | 90MG | Prescription | |||
| NDA205755 - NOVARTIS | |||||||
| ZYKADIA | CERITINIB | CAPSULE;ORAL | 150MG | Discontinued | |||
| NDA204822 - NOVARTIS | |||||||
| IZBA | TRAVOPROST | SOLUTION/DROPS;OPHTHALMIC | 0.003% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA204114 - NOVARTIS | |||||||
| MEKINIST | TRAMETINIB DIMETHYL SULFOXIDE | TABLET;ORAL | EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| MEKINIST | TRAMETINIB DIMETHYL SULFOXIDE | TABLET;ORAL | EQ 0.5MG | Prescription | |||
| MEKINIST | TRAMETINIB DIMETHYL SULFOXIDE | TABLET;ORAL | EQ 2MG | Prescription | |||
| NDA203985 - NOVARTIS PHARM | |||||||
| AFINITOR DISPERZ | EVEROLIMUS | TABLET, FOR SUSPENSION;ORAL | 2MG | Prescription | |||
| AFINITOR DISPERZ | EVEROLIMUS | TABLET, FOR SUSPENSION;ORAL | 3MG | Prescription | |||
| AFINITOR DISPERZ | EVEROLIMUS | TABLET, FOR SUSPENSION;ORAL | 5MG | Prescription | |||
| NDA202806 - NOVARTIS | |||||||
| TAFINLAR | DABRAFENIB MESYLATE | CAPSULE;ORAL | EQ 75MG BASE | Prescription | |||
| TAFINLAR | DABRAFENIB MESYLATE | CAPSULE;ORAL | EQ 50MG BASE | Prescription | |||
| NDA200045 - NOVARTIS | |||||||
| AMTURNIDE | ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | EQ 150MG BASE;EQ 5MG BASE;12.5MG | Discontinued | |||
| AMTURNIDE | ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | EQ 300MG BASE;EQ 5MG BASE;12.5MG | Discontinued | |||
| AMTURNIDE | ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | EQ 300MG BASE;EQ 5MG BASE;25MG | Discontinued | |||
| AMTURNIDE | ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | EQ 300MG BASE;EQ 10MG BASE;12.5MG | Discontinued | |||
| AMTURNIDE | ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | EQ 300MG BASE;EQ 10MG BASE;25MG | Discontinued | |||
| BLA125504 - NOVARTIS PHARMS CORP | |||||||
| COSENTYX | SECUKINUMAB | INJECTABLE;INJECTION | 150MG/ML | Prescription | |||
| BLA125326 - NOVARTIS | |||||||
| ARZERRA | OFATUMUMAB | INJECTABLE; INJECTION | 100MG/5ML | Prescription | |||
| KESIMPTA | OFATUMUMAB | SOLUTION;SUBCUTANEOUS | 20MG/0.4ML | Prescription | |||
| BLA125319 - NOVARTIS PHARMS | |||||||
| ILARIS | CANAKINUMAB | INJECTABLE; SUBCUTANEOUS | 180MG | Prescription | |||
| BLA103764 - NOVARTIS | |||||||
| SIMULECT | BASILIXIMAB | VIAL; SINGLE-USE | 10MG | Prescription | |||
| SIMULECT | BASILIXIMAB | VIAL; SINGLE-USE | 20MG | Prescription | |||
| ANDA089047 - NOVARTIS | |||||||
| SULF-15 | SULFACETAMIDE SODIUM | SOLUTION/DROPS;OPHTHALMIC | 15% | Discontinued | |||
| ANDA088791 - NOVARTIS | |||||||
| VASOCIDIN | PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM | OINTMENT;OPHTHALMIC | 0.5%;10% | Discontinued | |||
| ANDA086765 - NOVARTIS | |||||||
| IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | CONCENTRATE;ORAL | 25MG/ML | Discontinued | |||
| ANDA085148 - NOVARTIS | |||||||
| ASBRON | THEOPHYLLINE SODIUM GLYCINATE | TABLET;ORAL | EQ 150MG BASE | Discontinued | |||
| ANDA084811 - NOVARTIS | |||||||
| APRESAZIDE | HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | CAPSULE;ORAL | 100MG;50MG | Discontinued | |||
| ANDA084810 - NOVARTIS | |||||||
| APRESAZIDE | HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | CAPSULE;ORAL | 50MG;50MG | Discontinued | |||
| ANDA084735 - NOVARTIS | |||||||
| APRESAZIDE | HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | CAPSULE;ORAL | 25MG;25MG | Discontinued | |||
| ANDA083149 - NOVARTIS | |||||||
| PBZ | TRIPELENNAMINE HYDROCHLORIDE | TABLET;ORAL | 25MG | Discontinued | |||
| ANDA080935 - NOVARTIS | |||||||
| INH | ISONIAZID | TABLET;ORAL | 300MG | Discontinued | |||
| ANDA080751 - NOVARTIS | |||||||
| INFLAMASE MILD | PREDNISOLONE SODIUM PHOSPHATE | SOLUTION/DROPS;OPHTHALMIC | EQ 0.11% PHOSPHATE | Discontinued | |||
| INFLAMASE FORTE | PREDNISOLONE SODIUM PHOSPHATE | SOLUTION/DROPS;OPHTHALMIC | EQ 0.9% PHOSPHATE | Discontinued | |||
| ANDA080235 - NOVARTIS | |||||||
| VASOCON | NAPHAZOLINE HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | 0.1% | Discontinued | |||
| ANDA080025 - NOVARTIS | |||||||
| SULF-10 | SULFACETAMIDE SODIUM | SOLUTION/DROPS;OPHTHALMIC | 10% | Discontinued | |||
| ANDA074857 - NOVARTIS | |||||||
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | CAPSULE;ORAL | 25MG;37.5MG | Discontinued | |||
| ANDA073677 - NOVARTIS | |||||||
| CARBASTAT | CARBACHOL | SOLUTION;INTRAOCULAR | 0.01% | Discontinued | |||
| ANDA072687 - NOVARTIS | |||||||
| FOAMICON | ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE | TABLET, CHEWABLE;ORAL | 80MG;20MG | Discontinued | |||
| ANDA070185 - NOVARTIS | |||||||
| FLUOR-OP | FLUOROMETHOLONE | SUSPENSION/DROPS;OPHTHALMIC | 0.1% | Discontinued | |||
| ANDA062566 - NOVARTIS | |||||||
| DEXACIDIN | DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | OINTMENT;OPHTHALMIC | 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM | Discontinued | |||
| ANDA062544 - NOVARTIS | |||||||
| DEXACIDIN | DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | SUSPENSION/DROPS;OPHTHALMIC | 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | Discontinued | |||
| ANDA062501 - NOVARTIS | |||||||
| GENTACIDIN | GENTAMICIN SULFATE | OINTMENT;OPHTHALMIC | EQ 0.3% BASE | Discontinued | |||
| ANDA062480 - NOVARTIS | |||||||
| GENTACIDIN | GENTAMICIN SULFATE | SOLUTION/DROPS;OPHTHALMIC | EQ 0.3% BASE | Discontinued | |||
| NDA050791 - NOVARTIS | |||||||
| MYFORTIC | MYCOPHENOLIC SODIUM | TABLET, DELAYED RELEASE;ORAL | EQ 180MG BASE | Prescription | |||
| MYFORTIC | MYCOPHENOLIC SODIUM | TABLET, DELAYED RELEASE;ORAL | EQ 360MG BASE | Prescription | |||
| NDA050738 - NOVARTIS | |||||||
| NEORAL | CYCLOSPORINE | CAPSULE; ORAL | 25MG | Prescription | |||
| NEORAL | CYCLOSPORINE | CAPSULE; ORAL | 100MG | Prescription | |||
| NDA050737 - NOVARTIS | |||||||
| NEORAL | CYCLOSPORINE | CAPSULE; ORAL | 25MG | Prescription | |||
| NEORAL | CYCLOSPORINE | CAPSULE; ORAL | 100MG | Prescription | |||
| NDA050736 - NOVARTIS | |||||||
| NEORAL | CYCLOSPORINE | CAPSULE; ORAL | 100MG | Prescription | |||
| NEORAL | CYCLOSPORINE | CAPSULE; ORAL | 25MG | Prescription | |||
| NDA050735 - NOVARTIS | |||||||
| NEORAL | CYCLOSPORINE | CAPSULE; ORAL | 25MG | Prescription | |||
| NEORAL | CYCLOSPORINE | CAPSULE; ORAL | 100MG | Prescription | |||
| NDA050716 - NOVARTIS | |||||||
| NEORAL | CYCLOSPORINE | SOLUTION;ORAL | 100MG/ML | Prescription | |||
| NDA050715 - NOVARTIS | |||||||
| NEORAL | CYCLOSPORINE | CAPSULE;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NEORAL | CYCLOSPORINE | CAPSULE;ORAL | 100MG | Prescription | |||
| NEORAL | CYCLOSPORINE | CAPSULE;ORAL | 25MG | Prescription | |||
| NDA050625 - NOVARTIS | |||||||
| SANDIMMUNE | CYCLOSPORINE | CAPSULE;ORAL | 50MG | Prescription | |||
| SANDIMMUNE | CYCLOSPORINE | CAPSULE;ORAL | 100MG | Prescription | |||
| SANDIMMUNE | CYCLOSPORINE | CAPSULE;ORAL | 25MG | Prescription | |||
| NDA050616 - NOVARTIS | |||||||
| TOBRADEX | DEXAMETHASONE; TOBRAMYCIN | OINTMENT;OPHTHALMIC | 0.1%;0.3% | Prescription | |||
| NDA050574 - NOVARTIS | |||||||
| SANDIMMUNE | CYCLOSPORINE | SOLUTION;ORAL | 100MG/ML | Prescription | |||
| NDA050573 - NOVARTIS | |||||||
| SANDIMMUNE | CYCLOSPORINE | INJECTABLE;INJECTION | 50MG/ML | Prescription | |||
| NDA050555 - NOVARTIS | |||||||
| TOBREX | TOBRAMYCIN | OINTMENT;OPHTHALMIC | 0.3% | Prescription | |||
| NDA050541 - NOVARTIS | |||||||
| TOBREX | TOBRAMYCIN | SOLUTION/DROPS;OPHTHALMIC | 0.3% | Discontinued | |||
| NDA022545 - NOVARTIS | |||||||
| TEKAMLO | ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE | TABLET;ORAL | EQ 150MG BASE;EQ 5MG BASE | Discontinued | |||
| TEKAMLO | ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE | TABLET;ORAL | EQ 150MG BASE;EQ 10MG BASE | Discontinued | |||
| TEKAMLO | ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE | TABLET;ORAL | EQ 300MG BASE;EQ 5MG BASE | Discontinued | |||
| TEKAMLO | ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE | TABLET;ORAL | EQ 300MG BASE;EQ 10MG BASE | Discontinued | |||
| NDA022527 - NOVARTIS | |||||||
| GILENYA | FINGOLIMOD HYDROCHLORIDE | CAPSULE;ORAL | EQ 0.25MG BASE | Prescription | |||
| GILENYA | FINGOLIMOD HYDROCHLORIDE | CAPSULE;ORAL | EQ 0.5MG BASE | Prescription | |||
| NDA022470 - NOVARTIS | |||||||
| NEXCEDE | KETOPROFEN | FILM;ORAL | 12.5MG | Discontinued | |||
| NDA022465 - NOVARTIS | |||||||
| VOTRIENT | PAZOPANIB HYDROCHLORIDE | TABLET;ORAL | EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| VOTRIENT | PAZOPANIB HYDROCHLORIDE | TABLET;ORAL | EQ 200MG BASE | Prescription | |||
| NDA022383 - NOVARTIS | |||||||
| ARCAPTA NEOHALER | INDACATEROL MALEATE | POWDER;INHALATION | EQ 75MCG BASE | Discontinued | |||
| NDA022334 - NOVARTIS | |||||||
| AFINITOR | EVEROLIMUS | TABLET;ORAL | 10MG | Prescription | |||
| AFINITOR | EVEROLIMUS | TABLET;ORAL | 2.5MG | Prescription | |||
| AFINITOR | EVEROLIMUS | TABLET;ORAL | 5MG | Prescription | |||
| AFINITOR | EVEROLIMUS | TABLET;ORAL | 7.5MG | Prescription | |||
| NDA022314 - NOVARTIS | |||||||
| EXFORGE HCT | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET;ORAL | EQ 5MG BASE;12.5MG;160MG | Prescription | |||
| EXFORGE HCT | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET;ORAL | EQ 5MG BASE;25MG;160MG | Prescription | |||
| EXFORGE HCT | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET;ORAL | EQ 10MG BASE;12.5MG;160MG | Prescription | |||
| EXFORGE HCT | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET;ORAL | EQ 10MG BASE;25MG;160MG | Prescription | |||
| EXFORGE HCT | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET;ORAL | EQ 10MG BASE;25MG;320MG | Prescription | |||
| NDA022291 - NOVARTIS | |||||||
| PROMACTA | ELTROMBOPAG OLAMINE | TABLET;ORAL | EQ 25MG ACID | Prescription | |||
| PROMACTA | ELTROMBOPAG OLAMINE | TABLET;ORAL | EQ 50MG ACID | Prescription | |||
| PROMACTA | ELTROMBOPAG OLAMINE | TABLET;ORAL | EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| PROMACTA | ELTROMBOPAG OLAMINE | TABLET;ORAL | EQ 75MG ACID | Prescription | |||
| PROMACTA | ELTROMBOPAG OLAMINE | TABLET;ORAL | EQ 12.5MG ACID | Prescription | |||
| NDA022268 - NOVARTIS | |||||||
| COARTEM | ARTEMETHER; LUMEFANTRINE | TABLET;ORAL | 20MG;120MG | Prescription | |||
| NDA022217 - NOVARTIS | |||||||
| VALTURNA | ALISKIREN HEMIFUMARATE; VALSARTAN | TABLET;ORAL | EQ 150MG BASE;160MG | Discontinued | |||
| VALTURNA | ALISKIREN HEMIFUMARATE; VALSARTAN | TABLET;ORAL | EQ 300MG BASE;320MG | Discontinued | |||
| NDA022154 - NOVARTIS | |||||||
| TYZEKA | TELBIVUDINE | SOLUTION;ORAL | 100MG/5ML | Discontinued | |||
| NDA022071 - NOVARTIS | |||||||
| LAMISIL | TERBINAFINE HYDROCHLORIDE | GRANULE;ORAL | EQ 125MG BASE/PACKET | Discontinued | |||
| LAMISIL | TERBINAFINE HYDROCHLORIDE | GRANULE;ORAL | EQ 187.5MG BASE/PACKET | Discontinued | |||
| NDA022068 - NOVARTIS | |||||||
| TASIGNA | NILOTINIB HYDROCHLORIDE | CAPSULE;ORAL | EQ 200MG BASE | Prescription | |||
| TASIGNA | NILOTINIB HYDROCHLORIDE | CAPSULE;ORAL | EQ 50MG BASE | Prescription | |||
| TASIGNA | NILOTINIB HYDROCHLORIDE | CAPSULE;ORAL | EQ 150MG BASE | Prescription | |||
| NDA022059 - NOVARTIS | |||||||
| TYKERB | LAPATINIB DITOSYLATE | TABLET;ORAL | EQ 250MG BASE | Prescription | |||
| NDA022011 - NOVARTIS | |||||||
| TYZEKA | TELBIVUDINE | TABLET;ORAL | 600MG | Discontinued | |||
| NDA021990 - NOVARTIS | |||||||
| EXFORGE | AMLODIPINE BESYLATE; VALSARTAN | TABLET;ORAL | EQ 5MG BASE;320MG | Prescription | |||
| EXFORGE | AMLODIPINE BESYLATE; VALSARTAN | TABLET;ORAL | EQ 10MG BASE;320MG | Prescription | |||
| EXFORGE | AMLODIPINE BESYLATE; VALSARTAN | TABLET;ORAL | EQ 5MG BASE;160MG | Prescription | |||
| EXFORGE | AMLODIPINE BESYLATE; VALSARTAN | TABLET;ORAL | EQ 10MG BASE;160MG | Prescription | |||
| NDA021882 - NOVARTIS | |||||||
| EXJADE | DEFERASIROX | TABLET, FOR SUSPENSION;ORAL | 125MG | Prescription | |||
| EXJADE | DEFERASIROX | TABLET, FOR SUSPENSION;ORAL | 250MG | Prescription | |||
| EXJADE | DEFERASIROX | TABLET, FOR SUSPENSION;ORAL | 500MG | Prescription | |||
| NDA021861 - NOVARTIS | |||||||
| PATANASE | OLOPATADINE HYDROCHLORIDE | SPRAY, METERED;NASAL | 0.665MG/SPRAY | Discontinued | |||
| NDA021592 - NOVARTIS | |||||||
| FORADIL CERTIHALER | FORMOTEROL FUMARATE | POWDER;INHALATION | 0.0085MG/INH | Discontinued | |||
| NDA021588 - NOVARTIS | |||||||
| GLEEVEC | IMATINIB MESYLATE | TABLET;ORAL | EQ 100MG BASE | Prescription | |||
| GLEEVEC | IMATINIB MESYLATE | TABLET;ORAL | EQ 400MG BASE | Prescription | |||
| NDA021560 - NOVARTIS | |||||||
| ZORTRESS | EVEROLIMUS | TABLET;ORAL | 0.25MG | Prescription | |||
| ZORTRESS | EVEROLIMUS | TABLET;ORAL | 0.75MG | Prescription | |||
| ZORTRESS | EVEROLIMUS | TABLET;ORAL | 1MG | Prescription | |||
| ZORTRESS | EVEROLIMUS | TABLET;ORAL | 0.5MG | Prescription | |||
| NDA021386 - NOVARTIS | |||||||
| ZOMETA | ZOLEDRONIC ACID | INJECTABLE; IV (INFUSION) | EQ 4MG BASE/VIAL | Prescription | |||
| NDA021335 - NOVARTIS | |||||||
| GLEEVEC | IMATINIB MESYLATE | CAPSULE;ORAL | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| GLEEVEC | IMATINIB MESYLATE | CAPSULE;ORAL | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA021285 - NOVARTIS | |||||||
| TRILEPTAL | OXCARBAZEPINE | SUSPENSION;ORAL | 300MG/5ML | Prescription | |||
| NDA021283 - NOVARTIS | |||||||
| DIOVAN | VALSARTAN | TABLET;ORAL | 40MG | Prescription | |||
| DIOVAN | VALSARTAN | TABLET;ORAL | 320MG | Prescription | |||
| DIOVAN | VALSARTAN | TABLET;ORAL | 160MG | Prescription | |||
| DIOVAN | VALSARTAN | TABLET;ORAL | 80MG | Prescription | |||
| NDA021279 - NOVARTIS | |||||||
| FORADIL | FORMOTEROL FUMARATE | POWDER; INHALATION | 0.012MG/INH | Discontinued | |||
| NDA021223 - NOVARTIS | |||||||
| ZOMETA | ZOLEDRONIC ACID | INJECTABLE;INTRAVENOUS | EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ZOMETA | ZOLEDRONIC ACID | INJECTABLE;INTRAVENOUS | EQ 4MG BASE/100ML | Discontinued | |||
| ZOMETA | ZOLEDRONIC ACID | INJECTABLE;INTRAVENOUS | EQ 4MG BASE/5ML | Discontinued | |||
| NDA021204 - NOVARTIS | |||||||
| STARLIX | NATEGLINIDE | TABLET;ORAL | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| STARLIX | NATEGLINIDE | TABLET;ORAL | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA021167 - NOVARTIS | |||||||
| VIVELLE | ESTRADIOL | FILM, EXTENDED RELEASE; TRANSDERMAL | 0.0375MG/24HR | Discontinued | |||
| VIVELLE | ESTRADIOL | FILM, EXTENDED RELEASE; TRANSDERMAL | 0.05MG/24HR | Prescription | |||
| VIVELLE | ESTRADIOL | FILM, EXTENDED RELEASE; TRANSDERMAL | 0.075MG/24HR | Discontinued | |||
| VIVELLE | ESTRADIOL | FILM, EXTENDED RELEASE; TRANSDERMAL | 0.025MG/24HR | Discontinued | |||
| VIVELLE | ESTRADIOL | FILM, EXTENDED RELEASE; TRANSDERMAL | 0.1MG/24HR | Prescription | |||
| NDA021082 - NOVARTIS | |||||||
| TAVIST ALLERGY/SINUS/HEADACHE | ACETAMINOPHEN; CLEMASTINE FUMARATE; PSEUDOEPHEDRINE HYDROCHLORIDE | TABLET;ORAL | 500MG;EQ 0.25MG BASE;30MG | Discontinued | |||
| NDA021025 - NOVARTIS | |||||||
| EXELON | RIVASTIGMINE TARTRATE | SOLUTION;ORAL | EQ 2MG BASE/ML | Discontinued | |||
| NDA021014 - NOVARTIS | |||||||
| TRILEPTAL | OXCARBAZEPINE | TABLET;ORAL | 300MG | Prescription | |||
| TRILEPTAL | OXCARBAZEPINE | TABLET;ORAL | 600MG | Prescription | |||
| TRILEPTAL | OXCARBAZEPINE | TABLET;ORAL | 150MG | Prescription | |||
| NDA021008 - NOVARTIS | |||||||
| SANDOSTATIN LAR | OCTREOTIDE ACETATE | INJECTABLE;INJECTION | EQ 10MG BASE/VIAL | Prescription | |||
| SANDOSTATIN LAR | OCTREOTIDE ACETATE | INJECTABLE;INJECTION | EQ 20MG BASE/VIAL | Prescription | |||
| SANDOSTATIN LAR | OCTREOTIDE ACETATE | INJECTABLE;INJECTION | EQ 30MG BASE/VIAL | Prescription | |||
| NDA020961 - NOVARTIS | |||||||
| VITRAVENE PRESERVATIVE FREE | FOMIVIRSEN SODIUM | INJECTABLE;INJECTION | 6.6MG/ML | Discontinued | |||
| NDA020927 - NOVARTIS | |||||||
| AREDIA | PAMIDRONATE DISODIUM | INJECTABLE;INJECTION | 60MG/VIAL | Prescription | |||
| AREDIA | PAMIDRONATE DISODIUM | INJECTABLE; INJECTION | 90MG/VIAL | Prescription | |||
| AREDIA | PAMIDRONATE DISODIUM | INJECTABLE; INJECTION | 30MG/VIAL | Prescription | |||
| NDA020831 - NOVARTIS | |||||||
| FORADIL | FORMOTEROL FUMARATE | POWDER;INHALATION | 0.012MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA020823 - NOVARTIS | |||||||
| EXELON | RIVASTIGMINE TARTRATE | CAPSULE;ORAL | EQ 1.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| EXELON | RIVASTIGMINE TARTRATE | CAPSULE;ORAL | EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| EXELON | RIVASTIGMINE TARTRATE | CAPSULE;ORAL | EQ 4.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| EXELON | RIVASTIGMINE TARTRATE | CAPSULE;ORAL | EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA020818 - NOVARTIS | |||||||
| DIOVAN HCT | HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET;ORAL | 12.5MG;80MG | Prescription | |||
| DIOVAN HCT | HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET;ORAL | 12.5MG;160MG | Prescription | |||
| DIOVAN HCT | HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET;ORAL | 25MG;160MG | Prescription | |||
| DIOVAN HCT | HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET;ORAL | 12.5MG;320MG | Prescription | |||
| DIOVAN HCT | HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET;ORAL | 25MG;320MG | Prescription | |||
| NDA020726 - NOVARTIS PHARMS | |||||||
| FEMARA | LETROZOLE | TABLET;ORAL | 2.5MG | Prescription | |||
| NDA020706 - NOVARTIS | |||||||
| EMADINE | EMEDASTINE DIFUMARATE | SOLUTION/DROPS;OPHTHALMIC | 0.05% | Discontinued | |||
| NDA020665 - NOVARTIS | |||||||
| DIOVAN | VALSARTAN | CAPSULE;ORAL | 160MG | Discontinued | |||
| DIOVAN | VALSARTAN | CAPSULE;ORAL | 80MG | Discontinued | |||
| NDA020539 - NOVARTIS | |||||||
| LAMISIL | TERBINAFINE HYDROCHLORIDE | TABLET;ORAL | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA020363 - NOVARTIS | |||||||
| FAMVIR | FAMCICLOVIR | TABLET;ORAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| FAMVIR | FAMCICLOVIR | TABLET;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| FAMVIR | FAMCICLOVIR | TABLET;ORAL | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA020261 - NOVARTIS | |||||||
| LESCOL | FLUVASTATIN SODIUM | CAPSULE;ORAL | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| LESCOL | FLUVASTATIN SODIUM | CAPSULE;ORAL | EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA020254 - NOVARTIS | |||||||
| VOLTAREN-XR | DICLOFENAC SODIUM | TABLET, EXTENDED RELEASE;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA020234 - NOVARTIS | |||||||
| TEGRETOL-XR | CARBAMAZEPINE | TABLET, EXTENDED RELEASE;ORAL | 200MG | Prescription | |||
| TEGRETOL-XR | CARBAMAZEPINE | TABLET, EXTENDED RELEASE;ORAL | 400MG | Prescription | |||
| TEGRETOL-XR | CARBAMAZEPINE | TABLET, EXTENDED RELEASE;ORAL | 100MG | Prescription | |||
| NDA020219 - NOVARTIS | |||||||
| LIVOSTIN | LEVOCABASTINE HYDROCHLORIDE | SUSPENSION/DROPS;OPHTHALMIC | EQ 0.05% BASE | Discontinued | |||
| NDA020192 - NOVARTIS | |||||||
| LAMISIL | TERBINAFINE HYDROCHLORIDE | CREAM;TOPICAL | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA020191 - NOVARTIS | |||||||
| ALOMIDE | LODOXAMIDE TROMETHAMINE | SOLUTION/DROPS;OPHTHALMIC | EQ 0.1% BASE | Prescription | |||
| NDA020144 - NOVARTIS | |||||||
| TRANSDERM-NITRO | NITROGLYCERIN | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.1MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| TRANSDERM-NITRO | NITROGLYCERIN | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.2MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| TRANSDERM-NITRO | NITROGLYCERIN | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.4MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| TRANSDERM-NITRO | NITROGLYCERIN | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.6MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| TRANSDERM-NITRO | NITROGLYCERIN | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.8MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA020142 - NOVARTIS | |||||||
| CATAFLAM | DICLOFENAC POTASSIUM | TABLET;ORAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| CATAFLAM | DICLOFENAC POTASSIUM | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA020037 - NOVARTIS | |||||||
| VOLTAREN | DICLOFENAC SODIUM | SOLUTION/DROPS;OPHTHALMIC | 0.1% | Discontinued | |||
| NDA020036 - NOVARTIS | |||||||
| AREDIA | PAMIDRONATE DISODIUM | INJECTABLE;INJECTION | 30MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| AREDIA | PAMIDRONATE DISODIUM | INJECTABLE;INJECTION | 90MG/VIAL | Discontinued | |||
| AREDIA | PAMIDRONATE DISODIUM | INJECTABLE;INJECTION | 60MG/VIAL | Discontinued | |||
| NDA019972 - NOVARTIS | |||||||
| OCUPRESS | CARTEOLOL HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA019845 - NOVARTIS | |||||||
| BETOPTIC S | BETAXOLOL HYDROCHLORIDE | SUSPENSION/DROPS;OPHTHALMIC | EQ 0.25% BASE | Prescription | |||
| NDA019786 - NOVARTIS | |||||||
| LOPRESSOR | METOPROLOL FUMARATE | TABLET, EXTENDED RELEASE;ORAL | EQ 200MG TARTRATE | Discontinued | |||
| LOPRESSOR | METOPROLOL FUMARATE | TABLET, EXTENDED RELEASE;ORAL | EQ 300MG TARTRATE | Discontinued | |||
| LOPRESSOR | METOPROLOL FUMARATE | TABLET, EXTENDED RELEASE;ORAL | EQ 400MG TARTRATE | Discontinued | |||
| LOPRESSOR | METOPROLOL FUMARATE | TABLET, EXTENDED RELEASE;ORAL | EQ 100MG TARTRATE | Discontinued | |||
| NDA019667 - NOVARTIS | |||||||
| SANDOSTATIN | OCTREOTIDE ACETATE | INJECTABLE;INJECTION | EQ 0.1MG BASE/ML | Prescription | |||
| SANDOSTATIN | OCTREOTIDE ACETATE | INJECTABLE;INJECTION | EQ 0.5MG BASE/ML | Prescription | |||
| SANDOSTATIN | OCTREOTIDE ACETATE | INJECTABLE;INJECTION | EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| SANDOSTATIN | OCTREOTIDE ACETATE | INJECTABLE;INJECTION | EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| SANDOSTATIN | OCTREOTIDE ACETATE | INJECTABLE;INJECTION | EQ 0.05MG BASE/ML | Prescription | |||
| NDA019500 - NOVARTIS | |||||||
| LAMPRENE | CLOFAZIMINE | CAPSULE;ORAL | 50MG | Discontinued | |||
| LAMPRENE | CLOFAZIMINE | CAPSULE;ORAL | 100MG | Discontinued | |||
| NDA019451 - NOVARTIS | |||||||
| LOPRESSIDONE | CHLORTHALIDONE; METOPROLOL TARTRATE | CAPSULE;ORAL | 25MG;100MG | Discontinued | |||
| LOPRESSIDONE | CHLORTHALIDONE; METOPROLOL TARTRATE | CAPSULE;ORAL | 25MG;200MG | Discontinued | |||
| NDA019381 - NOVARTIS | |||||||
| TEN-K | POTASSIUM CHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 10MEQ | Discontinued | |||
| NDA019201 - NOVARTIS | |||||||
| VOLTAREN | DICLOFENAC SODIUM | TABLET, DELAYED RELEASE;ORAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| VOLTAREN | DICLOFENAC SODIUM | TABLET, DELAYED RELEASE;ORAL | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| VOLTAREN | DICLOFENAC SODIUM | TABLET, DELAYED RELEASE;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA019081 - NOVARTIS | |||||||
| ESTRADERM | ESTRADIOL | SYSTEM;TRANSDERMAL | 0.05MG/24HR | Discontinued | |||
| ESTRADERM | ESTRADIOL | SYSTEM;TRANSDERMAL | 0.1MG/24HR | Discontinued | |||
| NDA018988 - NOVARTIS | |||||||
| VASOCIDIN | PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM | SOLUTION/DROPS;OPHTHALMIC | EQ 0.23% PHOSPHATE;10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA018927 - NOVARTIS | |||||||
| TEGRETOL | CARBAMAZEPINE | SUSPENSION;ORAL | 100MG/5ML | Prescription | |||
| NDA018885 - NOVARTIS | |||||||
| EMBOLEX | DIHYDROERGOTAMINE MESYLATE; HEPARIN SODIUM; LIDOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.5MG/0.5ML;2,500 UNITS/0.5ML;5.33MG/0.5ML | Discontinued | |||
| EMBOLEX | DIHYDROERGOTAMINE MESYLATE; HEPARIN SODIUM; LIDOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.5MG/0.7ML;5,000 UNITS/0.7ML;7.46MG/0.7ML | Discontinued | |||
| NDA018872 - NOVARTIS | |||||||
| VISKAZIDE | HYDROCHLOROTHIAZIDE; PINDOLOL | TABLET;ORAL | 25MG;5MG | Discontinued | |||
| VISKAZIDE | HYDROCHLOROTHIAZIDE; PINDOLOL | TABLET;ORAL | 25MG;10MG | Discontinued | |||
| NDA018762 - NOVARTIS | |||||||
| BRETHAIRE | TERBUTALINE SULFATE | AEROSOL, METERED;INHALATION | 0.2MG/INH | Discontinued | |||
| NDA018746 - NOVARTIS | |||||||
| VASOCON-A | ANTAZOLINE PHOSPHATE; NAPHAZOLINE HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | 0.5%;0.05% | Discontinued | |||
| NDA018706 - NOVARTIS | |||||||
| HYDERGINE LC | ERGOLOID MESYLATES | CAPSULE;ORAL | 1MG | Discontinued | |||
| NDA018704 - NOVARTIS | |||||||
| LOPRESSOR | METOPROLOL TARTRATE | INJECTABLE;INJECTION | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA018675 - NOVARTIS | |||||||
| TAVIST | CLEMASTINE FUMARATE | SYRUP;ORAL | EQ 0.5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA018470 - NOVARTIS | |||||||
| CIBACALCIN | CALCITONIN HUMAN | INJECTABLE;INJECTION | 0.5MG/VIAL | Discontinued | |||
| NDA018418 - NOVARTIS | |||||||
| HYDERGINE | ERGOLOID MESYLATES | SOLUTION;ORAL | 1MG/ML | Discontinued | |||
| NDA018285 - NOVARTIS | |||||||
| VISKEN | PINDOLOL | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| VISKEN | PINDOLOL | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA018281 - NOVARTIS | |||||||
| TEGRETOL | CARBAMAZEPINE | TABLET, CHEWABLE;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA018245 - NOVARTIS | |||||||
| SYNTOCINON | OXYTOCIN | INJECTABLE;INJECTION | 10USP UNITS/ML | Discontinued | |||
| NDA018202 - NOVARTIS | |||||||
| CYTADREN | AMINOGLUTETHIMIDE | TABLET;ORAL | 250MG | Discontinued | |||
| NDA018166 - NOVARTIS | |||||||
| TRASICOR | OXPRENOLOL HYDROCHLORIDE | CAPSULE;ORAL | 20MG | Discontinued | |||
| TRASICOR | OXPRENOLOL HYDROCHLORIDE | CAPSULE;ORAL | 40MG | Discontinued | |||
| TRASICOR | OXPRENOLOL HYDROCHLORIDE | CAPSULE;ORAL | 80MG | Discontinued | |||
| TRASICOR | OXPRENOLOL HYDROCHLORIDE | CAPSULE;ORAL | 160MG | Discontinued | |||
| NDA018115 - NOVARTIS | |||||||
| TRIAMINIC-12 | CHLORPHENIRAMINE MALEATE; PHENYLPROPANOLAMINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 12MG;75MG | Discontinued | |||
| NDA018029 - NOVARTIS | |||||||
| RITALIN-SR | METHYLPHENIDATE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA017993 - NOVARTIS | |||||||
| HYDERGINE | ERGOLOID MESYLATES | TABLET;ORAL | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| HYDERGINE | ERGOLOID MESYLATES | TABLET;ORAL | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA017923 - NOVARTIS | |||||||
| MELLARIL-S | THIORIDAZINE | SUSPENSION;ORAL | EQ 25MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| MELLARIL-S | THIORIDAZINE | SUSPENSION;ORAL | EQ 100MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA017869 - NOVARTIS | |||||||
| FUNDUSCEIN-25 | FLUORESCEIN SODIUM | INJECTABLE;INJECTION | 25% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA017851 - NOVARTIS | |||||||
| LIORESAL | BACLOFEN | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| LIORESAL | BACLOFEN | TABLET;ORAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA017661 - NOVARTIS | |||||||
| TAVIST | CLEMASTINE FUMARATE | TABLET;ORAL | 2.68MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| TAVIST-1 | CLEMASTINE FUMARATE | TABLET;ORAL | 1.34MG | Discontinued | |||
| TAVIST-1 | CLEMASTINE FUMARATE | TABLET;ORAL | 1.34MG | Discontinued | |||
| NDA017543 - NOVARTIS | |||||||
| LUDIOMIL | MAPROTILINE HYDROCHLORIDE | TABLET;ORAL | 25MG | Discontinued | |||
| LUDIOMIL | MAPROTILINE HYDROCHLORIDE | TABLET;ORAL | 50MG | Discontinued | |||
| LUDIOMIL | MAPROTILINE HYDROCHLORIDE | TABLET;ORAL | 75MG | Discontinued | |||
| NDA017476 - NOVARTIS | |||||||
| SLOW-K | POTASSIUM CHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 8MEQ | Discontinued | |||
| NDA017247 - NOVARTIS | |||||||
| SANOREX | MAZINDOL | TABLET;ORAL | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| SANOREX | MAZINDOL | TABLET;ORAL | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA016997 - NOVARTIS | |||||||
| SERENTIL | MESORIDAZINE BESYLATE | CONCENTRATE;ORAL | EQ 25MG BASE/ML | Discontinued | |||
| NDA016775 - NOVARTIS | |||||||
| SERENTIL | MESORIDAZINE BESYLATE | INJECTABLE;INJECTION | EQ 25MG BASE/ML | Discontinued | |||
| NDA016774 - NOVARTIS | |||||||
| SERENTIL | MESORIDAZINE BESYLATE | TABLET;ORAL | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| SERENTIL | MESORIDAZINE BESYLATE | TABLET;ORAL | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| SERENTIL | MESORIDAZINE BESYLATE | TABLET;ORAL | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| SERENTIL | MESORIDAZINE BESYLATE | TABLET;ORAL | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA016755 - NOVARTIS | |||||||
| DIAPID | LYPRESSIN | SOLUTION;NASAL | 0.185MG/ML | Discontinued | |||
| NDA016608 - NOVARTIS | |||||||
| TEGRETOL | CARBAMAZEPINE | TABLET;ORAL | 200MG | Prescription | |||
| NDA016379 - NOVARTIS | |||||||
| LOCORTEN | FLUMETHASONE PIVALATE | CREAM;TOPICAL | 0.03% | Discontinued | |||
| NDA016267 - NOVARTIS | |||||||
| DESFERAL | DEFEROXAMINE MESYLATE | INJECTABLE;INJECTION | 500MG/VIAL | Prescription | |||
| DESFERAL | DEFEROXAMINE MESYLATE | INJECTABLE;INJECTION | 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA016211 - NOVARTIS | |||||||
| MIOCHOL | ACETYLCHOLINE CHLORIDE | FOR SOLUTION;OPHTHALMIC | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA013553 - NOVARTIS | |||||||
| ESIMIL | GUANETHIDINE MONOSULFATE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 10MG;25MG | Discontinued | |||
| NDA013420 - NOVARTIS | |||||||
| TREST | METHIXENE HYDROCHLORIDE | TABLET;ORAL | 1MG | Discontinued | |||
| NDA013247 - NOVARTIS | |||||||
| TORECAN | THIETHYLPERAZINE MALEATE | SUPPOSITORY;RECTAL | 10MG | Discontinued | |||
| NDA012754 - NOVARTIS | |||||||
| TORECAN | THIETHYLPERAZINE MALATE | INJECTABLE;INJECTION | 5MG/ML | Discontinued | |||
| NDA012753 - NOVARTIS | |||||||
| TORECAN | THIETHYLPERAZINE MALEATE | TABLET;ORAL | 10MG | Discontinued | |||
| NDA012542 - NOVARTIS | |||||||
| TANDEARIL | OXYPHENBUTAZONE | TABLET;ORAL | 100MG | Discontinued | |||
| NDA012516 - NOVARTIS | |||||||
| SANSERT | METHYSERGIDE MALEATE | TABLET;ORAL | 2MG | Discontinued | |||
| NDA012329 - NOVARTIS | |||||||
| ISMELIN | GUANETHIDINE MONOSULFATE | TABLET;ORAL | EQ 10MG SULFATE | Discontinued | |||
| ISMELIN | GUANETHIDINE MONOSULFATE | TABLET;ORAL | EQ 25MG SULFATE | Discontinued | |||
| NDA012193 - NOVARTIS | |||||||
| SER-AP-ES | HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE | TABLET;ORAL | 25MG;15MG;0.1MG | Discontinued | |||
| NDA012026 - NOVARTIS | |||||||
| APRESOLINE-ESIDRIX | HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 25MG;15MG | Discontinued | |||
| NDA011878 - NOVARTIS | |||||||
| SERPASIL-ESIDRIX #1 | HYDROCHLOROTHIAZIDE; RESERPINE | TABLET;ORAL | 25MG;0.1MG | Discontinued | |||
| SERPASIL-ESIDRIX #2 | HYDROCHLOROTHIAZIDE; RESERPINE | TABLET;ORAL | 50MG;0.1MG | Discontinued | |||
| NDA011838 - NOVARTIS | |||||||
| TOFRANIL | IMIPRAMINE HYDROCHLORIDE | INJECTABLE;INJECTION | 12.5MG/ML | Discontinued | |||
| NDA011808 - NOVARTIS | |||||||
| MELLARIL | THIORIDAZINE HYDROCHLORIDE | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| MELLARIL | THIORIDAZINE HYDROCHLORIDE | TABLET;ORAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| MELLARIL | THIORIDAZINE HYDROCHLORIDE | TABLET;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| MELLARIL | THIORIDAZINE HYDROCHLORIDE | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| MELLARIL | THIORIDAZINE HYDROCHLORIDE | CONCENTRATE;ORAL | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| MELLARIL | THIORIDAZINE HYDROCHLORIDE | TABLET;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| MELLARIL | THIORIDAZINE HYDROCHLORIDE | TABLET;ORAL | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| MELLARIL | THIORIDAZINE HYDROCHLORIDE | TABLET;ORAL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| MELLARIL | THIORIDAZINE HYDROCHLORIDE | CONCENTRATE;ORAL | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA011793 - NOVARTIS | |||||||
| ESIDRIX | HYDROCHLOROTHIAZIDE | TABLET;ORAL | 25MG | Discontinued | |||
| ESIDRIX | HYDROCHLOROTHIAZIDE | TABLET;ORAL | 50MG | Discontinued | |||
| ESIDRIX | HYDROCHLOROTHIAZIDE | TABLET;ORAL | 100MG | Discontinued | |||
| NDA011556 - NOVARTIS | |||||||
| ANTURANE | SULFINPYRAZONE | TABLET;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ANTURANE | SULFINPYRAZONE | CAPSULE;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA010533 - NOVARTIS | |||||||
| PBZ-SR | TRIPELENNAMINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 100MG | Discontinued | |||
| PBZ-SR | TRIPELENNAMINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 50MG | Discontinued | |||
| NDA009436 - NOVARTIS | |||||||
| ACYLANID | ACETYLDIGITOXIN | TABLET;ORAL | 0.1MG | Discontinued | |||
| NDA009434 - NOVARTIS | |||||||
| SERPASIL | RESERPINE | INJECTABLE;INJECTION | 2.5MG/ML | Discontinued | |||
| NDA009296 - NOVARTIS | |||||||
| SERPASIL-APRESOLINE | HYDRALAZINE HYDROCHLORIDE; RESERPINE | TABLET;ORAL | 50MG;0.2MG | Discontinued | |||
| SERPASIL-APRESOLINE | HYDRALAZINE HYDROCHLORIDE; RESERPINE | TABLET;ORAL | 25MG;0.1MG | Discontinued | |||
| NDA009282 - NOVARTIS | |||||||
| CEDILANID-D | DESLANOSIDE | INJECTABLE;INJECTION | 0.2MG/ML | Discontinued | |||
| NDA009215 - NOVARTIS | |||||||
| RAUTENSIN | ALSEROXYLON | TABLET;ORAL | 2MG | Discontinued | |||
| NDA009115 - NOVARTIS | |||||||
| SERPASIL | RESERPINE | TABLET;ORAL | 0.1MG | Discontinued | |||
| SERPASIL | RESERPINE | TABLET;ORAL | 0.25MG | Discontinued | |||
| SERPASIL | RESERPINE | TABLET;ORAL | 1MG | Discontinued | |||
| SERPASIL | RESERPINE | ELIXIR;ORAL | 0.2MG/4ML | Discontinued | |||
| NDA009087 - NOVARTIS | |||||||
| HYDERGINE | ERGOLOID MESYLATES | TABLET;SUBLINGUAL | 0.5MG | Discontinued | |||
| HYDERGINE | ERGOLOID MESYLATES | TABLET;SUBLINGUAL | 1MG | Discontinued | |||
| NDA009000 - NOVARTIS | |||||||
| CAFERGOT | CAFFEINE; ERGOTAMINE TARTRATE | SUPPOSITORY;RECTAL | 100MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA008822 - NOVARTIS | |||||||
| PERCORTEN | DESOXYCORTICOSTERONE PIVALATE | INJECTABLE;INJECTION | 25MG/ML | Discontinued | |||
| NDA008492 - NOVARTIS | |||||||
| ANTRENYL | OXYPHENONIUM BROMIDE | TABLET;ORAL | 5MG | Discontinued | |||
| NDA008319 - NOVARTIS | |||||||
| BUTAZOLIDIN | PHENYLBUTAZONE | TABLET;ORAL | 100MG | Discontinued | |||
| BUTAZOLIDIN | PHENYLBUTAZONE | CAPSULE;ORAL | 100MG | Discontinued | |||
| NDA008303 - NOVARTIS | |||||||
| APRESOLINE | HYDRALAZINE HYDROCHLORIDE | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| APRESOLINE | HYDRALAZINE HYDROCHLORIDE | TABLET;ORAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| APRESOLINE | HYDRALAZINE HYDROCHLORIDE | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| APRESOLINE | HYDRALAZINE HYDROCHLORIDE | INJECTABLE;INJECTION | 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| APRESOLINE | HYDRALAZINE HYDROCHLORIDE | TABLET;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA008278 - NOVARTIS | |||||||
| REGITINE | PHENTOLAMINE MESYLATE | INJECTABLE;INJECTION | 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA006620 - NOVARTIS | |||||||
| CAFERGOT | CAFFEINE; ERGOTAMINE TARTRATE | TABLET;ORAL | 100MG;1MG | Discontinued | |||
| NDA006403 - NOVARTIS | |||||||
| PRISCOLINE | TOLAZOLINE HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/ML | Discontinued | |||
| NDA006203 - NOVARTIS | |||||||
| HEAVY SOLUTION NUPERCAINE | DIBUCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 2.5MG/ML | Discontinued | |||
| NDA006008 - NOVARTIS | |||||||
| MESANTOIN | MEPHENYTOIN | TABLET;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA005914 - NOVARTIS | |||||||
| PBZ | TRIPELENNAMINE HYDROCHLORIDE | TABLET;ORAL | 50MG | Discontinued | |||
| PBZ | TRIPELENNAMINE CITRATE | ELIXIR;ORAL | EQ 25MG HYDROCHLORIDE/5ML | Discontinued | |||
| NDA005151 - NOVARTIS | |||||||
| PERCORTEN | DESOXYCORTICOSTERONE ACETATE | PELLET;IMPLANTATION | 125MG | Discontinued | |||
| NDA003240 - NOVARTIS | |||||||
| METANDREN | METHYLTESTOSTERONE | TABLET;BUCCAL, SUBLINGUAL | 10MG | Discontinued | |||
| METANDREN | METHYLTESTOSTERONE | TABLET;BUCCAL, SUBLINGUAL | 25MG | Discontinued | |||
| METANDREN | METHYLTESTOSTERONE | TABLET;BUCCAL, SUBLINGUAL | 5MG | Discontinued | |||
| METANDREN | METHYLTESTOSTERONE | TABLET;BUCCAL, SUBLINGUAL | 10MG | Discontinued | |||