Sanofi (SNY)
FDA Applications
Note: This list only includes applications that have been responded to by the FDA.
| Application | Product Name | Active Ingredient | Form | Strength | Status | ||
|---|---|---|---|---|---|---|---|
| BLA761113 - SANOFI AVENTIS US | |||||||
| SARCLISA | ISATUXIMAB-IRFC | INJECTABLE;INJECTION | 100MG/5ML (20MG/ML) | Prescription | |||
| SARCLISA | ISATUXIMAB-IRFC | INJECTABLE;INJECTION | 500MG/25ML (20MG/ML) | Prescription | |||
| BLA761037 - SANOFI SYNTHELABO | |||||||
| KEVZARA | SARILUMAB | INJECTABLE;INJECTION | 150MG/1.14ML | Prescription | |||
| KEVZARA | SARILUMAB | INJECTABLE;INJECTION | 200MG/1.14ML | Prescription | |||
| NDA214429 - SANOFI | |||||||
| FEXINIDAZOLE | FEXINIDAZOLE | TABLET;ORAL | 600MG | Prescription | |||
| BLA209196 - SANOFI-AVENTIS US | |||||||
| ADMELOG | INSULIN LISPRO | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 1000 UNITS/10ML (100 UNITS/ML) | Prescription | |||
| ADMELOG SOLOSTAR | INSULIN LISPRO | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 300 UNITS/3ML (100 UNITS/ML) | Prescription | |||
| ADMELOG | INSULIN LISPRO | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 300 UNITS/3ML (100 UNITS/ML) | Prescription | |||
| NDA209090 - CHATTEM SANOFI | |||||||
| XYZAL ALLERGY 24HR | LEVOCETIRIZINE DIHYDROCHLORIDE | SOLUTION;ORAL | 2.5MG/5ML | Over-the-counter | |||
| NDA209089 - CHATTEM SANOFI | |||||||
| XYZAL ALLERGY 24HR | LEVOCETIRIZINE DIHYDROCHLORIDE | TABLET;ORAL | 5MG | Over-the-counter | |||
| BLA208673 - SANOFI-AVENTIS US | |||||||
| SOLIQUA 100/33 | INSULIN GLARGINE; LIXISENATIDE | SOLUTION;SUBCUTANEOUS | 300 UNITS/3ML;99MCG/3ML (100 UNITS/ML;33MCG/ML) | Prescription | |||
| BLA208471 - SANOFI-AVENTIS US | |||||||
| ADLYXIN | LIXISENATIDE | SOLUTION;SUBCUTANEOUS | 0.15MG/3ML (0.05MG/ML) | Prescription | |||
| ADLYXIN | LIXISENATIDE | SOLUTION;SUBCUTANEOUS | 0.3MG/3ML (0.1MG/ML) | Prescription | |||
| BLA206538 - SANOFI US SERVICES | |||||||
| TOUJEO SOLOSTAR | INSULIN GLARGINE RECOMBINANT | SOLUTION;SUBCUTANEOUS | 450 UNITS/1.5ML (300 UNITS/ML) | Prescription | |||
| TOUJEO MAX SOLOSTAR | INSULIN GLARGINE RECOMBINANT | SOLUTION;SUBCUTANEOUS | 900 UNITS/3ML (300 UNITS/ML) | Prescription | |||
| NDA202992 - SANOFI AVENTIS US | |||||||
| AUBAGIO | TERIFLUNOMIDE | TABLET;ORAL | 14MG | Prescription | |||
| AUBAGIO | TERIFLUNOMIDE | TABLET;ORAL | 7MG | Prescription | |||
| NDA201373 - CHATTEM SANOFI | |||||||
| CHILDREN'S ALLEGRA HIVES | FEXOFENADINE HYDROCHLORIDE | SUSPENSION;ORAL | 30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| CHILDREN'S ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | SUSPENSION;ORAL | 30MG/5ML | Over-the-counter | |||
| NDA201023 - SANOFI AVENTIS US | |||||||
| JEVTANA KIT | CABAZITAXEL | SOLUTION;INTRAVENOUS | 60MG/1.5ML (40MG/ML) | Prescription | |||
| BLA125418 - SANOFI AVENTIS US | |||||||
| ZALTRAP | ZIV-AFLIBERCEPT | INJECTABLE; INJECTION | 4MG | Prescription | |||
| BLA121559 - SANOFI-AVENTIS US | |||||||
| BLA103946 - SANOFI SYNTHELABO | |||||||
| ELITEK | RASBURICASE | VIAL; INTRAVENOUS | 1.5MG/VIAL | Prescription | |||
| ANDA089540 - SANOFI AVENTIS US | |||||||
| SLO-BID | THEOPHYLLINE | CAPSULE, EXTENDED RELEASE;ORAL | 125MG | Discontinued | |||
| ANDA089539 - SANOFI AVENTIS US | |||||||
| SLO-BID | THEOPHYLLINE | CAPSULE, EXTENDED RELEASE;ORAL | 75MG | Discontinued | |||
| ANDA088746 - SANOFI AVENTIS US | |||||||
| ACCURBRON | THEOPHYLLINE | SYRUP;ORAL | 150MG/15ML | Discontinued | |||
| ANDA088269 - SANOFI AVENTIS US | |||||||
| SLO-BID | THEOPHYLLINE | CAPSULE, EXTENDED RELEASE;ORAL | 50MG | Discontinued | |||
| ANDA087894 - SANOFI AVENTIS US | |||||||
| SLO-BID | THEOPHYLLINE | CAPSULE, EXTENDED RELEASE;ORAL | 300MG | Discontinued | |||
| ANDA087893 - SANOFI AVENTIS US | |||||||
| SLO-BID | THEOPHYLLINE | CAPSULE, EXTENDED RELEASE;ORAL | 200MG | Discontinued | |||
| ANDA087892 - SANOFI AVENTIS US | |||||||
| SLO-BID | THEOPHYLLINE | CAPSULE, EXTENDED RELEASE;ORAL | 100MG | Discontinued | |||
| ANDA087260 - SANOFI AVENTIS US | |||||||
| AZOLID | PHENYLBUTAZONE | CAPSULE;ORAL | 100MG | Discontinued | |||
| ANDA087091 - SANOFI AVENTIS US | |||||||
| AZOLID | PHENYLBUTAZONE | TABLET;ORAL | 100MG | Discontinued | |||
| ANDA085264 - SANOFI AVENTIS US | |||||||
| BRONKODYL | THEOPHYLLINE | CAPSULE;ORAL | 100MG | Discontinued | |||
| BRONKODYL | THEOPHYLLINE | CAPSULE;ORAL | 200MG | Discontinued | |||
| ANDA085206 - SANOFI AVENTIS US | |||||||
| SLO-PHYLLIN | THEOPHYLLINE | CAPSULE, EXTENDED RELEASE;ORAL | 60MG | Discontinued | |||
| ANDA085205 - SANOFI AVENTIS US | |||||||
| SLO-PHYLLIN | THEOPHYLLINE | CAPSULE, EXTENDED RELEASE;ORAL | 250MG | Discontinued | |||
| ANDA085204 - SANOFI AVENTIS US | |||||||
| SLO-PHYLLIN | THEOPHYLLINE | TABLET;ORAL | 200MG | Discontinued | |||
| ANDA085203 - SANOFI AVENTIS US | |||||||
| SLO-PHYLLIN | THEOPHYLLINE | CAPSULE, EXTENDED RELEASE;ORAL | 125MG | Discontinued | |||
| ANDA085202 - SANOFI AVENTIS US | |||||||
| SLO-PHYLLIN | THEOPHYLLINE | TABLET;ORAL | 100MG | Discontinued | |||
| ANDA085187 - SANOFI AVENTIS US | |||||||
| SLO-PHYLLIN | THEOPHYLLINE | SYRUP;ORAL | 80MG/15ML | Discontinued | |||
| ANDA083823 - SANOFI AVENTIS US | |||||||
| NICOLAR | NIACIN | TABLET;ORAL | 500MG | Discontinued | |||
| ANDA083518 - SANOFI AVENTIS US | |||||||
| DV | DIENESTROL | CREAM;VAGINAL | 0.01% | Discontinued | |||
| ANDA083517 - SANOFI AVENTIS US | |||||||
| DV | DIENESTROL | SUPPOSITORY;VAGINAL | 0.7MG | Discontinued | |||
| ANDA083459 - SANOFI AVENTIS US | |||||||
| VENTAIRE | PROTOKYLOL HYDROCHLORIDE | TABLET;ORAL | 2MG | Discontinued | |||
| ANDA080564 - SANOFI AVENTIS US | |||||||
| CYANOCOBALAMIN | CYANOCOBALAMIN | INJECTABLE;INJECTION | 1MG/ML | Discontinued | |||
| ANDA071159 - SANOFI AVENTIS US | |||||||
| NITRO-BID | NITROGLYCERIN | INJECTABLE;INJECTION | 10MG/ML | Discontinued | |||
| ANDA062659 - SANOFI AVENTIS US | |||||||
| CLAFORAN | CEFOTAXIME SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | Discontinued | |||
| CLAFORAN | CEFOTAXIME SODIUM | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | Discontinued | |||
| ANDA062303 - SANOFI AVENTIS US | |||||||
| RIFADIN | RIFAMPIN | CAPSULE;ORAL | 150MG | Discontinued | |||
| ANDA061884 - SANOFI AVENTIS US | |||||||
| RIFAMATE | ISONIAZID; RIFAMPIN | CAPSULE;ORAL | 150MG;300MG | Discontinued | |||
| ANDA061876 - SANOFI AVENTIS US | |||||||
| CERUBIDINE | DAUNORUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 20MG BASE/VIAL | Discontinued | |||
| ANDA061613 - SANOFI AVENTIS US | |||||||
| VANOBID | CANDICIDIN | TABLET;VAGINAL | 3MG | Discontinued | |||
| ANDA061596 - SANOFI AVENTIS US | |||||||
| VANOBID | CANDICIDIN | OINTMENT;VAGINAL | 0.6MG/GM | Discontinued | |||
| NDA050705 - SANOFI AVENTIS US | |||||||
| RIFATER | ISONIAZID; PYRAZINAMIDE; RIFAMPIN | TABLET;ORAL | 50MG;300MG;120MG | Discontinued | |||
| NDA050627 - SANOFI AVENTIS US | |||||||
| RIFADIN | RIFAMPIN | INJECTABLE;INJECTION | 600MG/VIAL | Prescription | |||
| NDA050420 - SANOFI AVENTIS US | |||||||
| RIFADIN | RIFAMPIN | CAPSULE;ORAL | 300MG | Discontinued | |||
| NDA022425 - SANOFI AVENTIS US | |||||||
| MULTAQ | DRONEDARONE HYDROCHLORIDE | TABLET;ORAL | EQ 400MG BASE | Prescription | |||
| NDA022273 - SANOFI AVENTIS US | |||||||
| OFORTA | FLUDARABINE PHOSPHATE | TABLET;ORAL | 10MG | Discontinued | |||
| NDA022157 - CHATTEM SANOFI | |||||||
| XYZAL | LEVOCETIRIZINE DIHYDROCHLORIDE | SOLUTION;ORAL | 2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA022138 - SANOFI AVENTIS US | |||||||
| LOVENOX | ENOXAPARIN SODIUM | INJECTABLE; INJECTION | 100MG/ML | Prescription | |||
| NDA022127 - SANOFI | |||||||
| RENVELA | SEVELAMER CARBONATE | TABLET;ORAL | 800MG | Prescription | |||
| NDA022064 - CHATTEM SANOFI | |||||||
| XYZAL | LEVOCETIRIZINE DIHYDROCHLORIDE | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA021963 - CHATTEM SANOFI | |||||||
| ALLEGRA | FEXOFENADINE HYDROCHLORIDE | SUSPENSION;ORAL | 30MG/5ML | Discontinued | |||
| NDA021909 - CHATTEM SANOFI | |||||||
| CHILDREN'S ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | TABLET, ORALLY DISINTEGRATING;ORAL | 30MG | Discontinued | |||
| CHILDREN'S ALLEGRA HIVES | FEXOFENADINE HYDROCHLORIDE | TABLET, ORALLY DISINTEGRATING;ORAL | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA021774 - SANOFI AVENTIS US | |||||||
| AMBIEN CR | ZOLPIDEM TARTRATE | TABLET, EXTENDED RELEASE;ORAL | 12.5MG | Prescription | |||
| AMBIEN CR | ZOLPIDEM TARTRATE | TABLET, EXTENDED RELEASE;ORAL | 6.25MG | Prescription | |||
| NDA021759 - SANOFI AVENTIS US | |||||||
| ELOXATIN | OXALIPLATIN | INJECTABLE;INTRAVENOUS | 50MG/10ML (5MG/ML) | Discontinued | |||
| ELOXATIN | OXALIPLATIN | INJECTABLE;INTRAVENOUS | 100MG/20ML (5MG/ML) | Discontinued | |||
| ELOXATIN | OXALIPLATIN | INJECTABLE;INTRAVENOUS | 200MG/40ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA021704 - CHATTEM SANOFI | |||||||
| ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 180MG;240MG | Over-the-counter | |||
| NDA021698 - CHATTEM SANOFI | |||||||
| ZANTAC 150 | RANITIDINE HYDROCHLORIDE | TABLET;ORAL | EQ 150MG BASE | Discontinued | |||
| ZANTAC 150 | RANITIDINE HYDROCHLORIDE | TABLET;ORAL | EQ 150MG BASE | Discontinued | |||
| BLA021629 - SANOFI AVENTIS US | |||||||
| APIDRA | INSULIN GLULISINE RECOMBINANT | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 1000 UNITS/10ML (100 UNITS/ML) | Prescription | |||
| APIDRA | INSULIN GLULISINE RECOMBINANT | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 300 UNITS/3ML (100 UNITS/ML) | Discontinued | |||
| APIDRA SOLOSTAR | INSULIN GLULISINE RECOMBINANT | INJECTABLE;SUBCUTANEOUS | 300 UNITS/3ML | Prescription | |||
| NDA021492 - SANOFI AVENTIS US | |||||||
| ELOXATIN | OXALIPLATIN | INJECTABLE;INTRAVENOUS | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ELOXATIN | OXALIPLATIN | INJECTABLE;INTRAVENOUS | 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA021144 - SANOFI AVENTIS US | |||||||
| KETEK | TELITHROMYCIN | TABLET;ORAL | 300MG | Discontinued | |||
| KETEK | TELITHROMYCIN | TABLET;ORAL | 400MG | Discontinued | |||
| BLA021081 - SANOFI AVENTIS US | |||||||
| LANTUS | INSULIN GLARGINE RECOMBINANT | INJECTABLE;INJECTION | 100 UNITS/ML | Prescription | |||
| LANTUS SOLOSTAR | INSULIN GLARGINE RECOMBINANT | INJECTABLE;INJECTION | 300 UNITS/3ML (100 UNITS/ML) | Prescription | |||
| NDA021027 - SANOFI | |||||||
| HECTOROL | DOXERCALCIFEROL | INJECTABLE;INJECTION | 4MCG/2ML (2MCG/ML) | Prescription | |||
| HECTOROL | DOXERCALCIFEROL | INJECTABLE;INJECTION | 2MCG/ML (2MCG/ML) | Prescription | |||
| NDA021024 - SANOFI AVENTIS US | |||||||
| PRIFTIN | RIFAPENTINE | TABLET;ORAL | 150MG | Prescription | |||
| NDA020955 - SANOFI AVENTIS US | |||||||
| FERRLECIT | FERRIC OXYHYDROXIDE | INJECTABLE;INJECTION | EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) | Prescription | |||
| NDA020905 - SANOFI AVENTIS US | |||||||
| ARAVA | LEFLUNOMIDE | TABLET;ORAL | 10MG | Prescription | |||
| ARAVA | LEFLUNOMIDE | TABLET;ORAL | 20MG | Prescription | |||
| ARAVA | LEFLUNOMIDE | TABLET;ORAL | 100MG | Prescription | |||
| NDA020872 - CHATTEM SANOFI | |||||||
| CHILDREN'S ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 60MG | Over-the-counter | |||
| ALLEGRA HIVES | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 180MG | Over-the-counter | |||
| ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 180MG | Over-the-counter | |||
| ALLEGRA HIVES | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 60MG | Discontinued | |||
| CHILDREN'S ALLEGRA HIVES | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 30MG | Discontinued | |||
| NDA020862 - SANOFI | |||||||
| HECTOROL | DOXERCALCIFEROL | CAPSULE;ORAL | 1MCG | Prescription | |||
| HECTOROL | DOXERCALCIFEROL | CAPSULE;ORAL | 0.5MCG | Prescription | |||
| HECTOROL | DOXERCALCIFEROL | CAPSULE;ORAL | 2.5MCG | Prescription | |||
| NDA020839 - SANOFI AVENTIS US | |||||||
| PLAVIX | CLOPIDOGREL BISULFATE | TABLET;ORAL | EQ 75MG BASE | Prescription | |||
| PLAVIX | CLOPIDOGREL BISULFATE | TABLET;ORAL | EQ 300MG BASE | Prescription | |||
| NDA020786 - CHATTEM SANOFI | |||||||
| ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION | FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 60MG;120MG | Over-the-counter | |||
| NDA020784 - SANOFI AVENTIS US | |||||||
| NASACORT HFA | TRIAMCINOLONE ACETONIDE | SPRAY, METERED;NASAL | 0.055MG/SPRAY | Discontinued | |||
| NDA020758 - SANOFI AVENTIS US | |||||||
| AVALIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | TABLET;ORAL | 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| AVALIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | TABLET;ORAL | 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| AVALIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | TABLET;ORAL | 12.5MG;300MG | Prescription | |||
| AVALIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | TABLET;ORAL | 12.5MG;150MG | Prescription | |||
| NDA020757 - SANOFI AVENTIS US | |||||||
| AVAPRO | IRBESARTAN | TABLET;ORAL | 75MG | Discontinued | |||
| AVAPRO | IRBESARTAN | TABLET;ORAL | 150MG | Prescription | |||
| AVAPRO | IRBESARTAN | TABLET;ORAL | 300MG | Prescription | |||
| NDA020750 - SANOFI AVENTIS US | |||||||
| TILADE | NEDOCROMIL SODIUM | SOLUTION;INHALATION | 0.5% | Discontinued | |||
| NDA020745 - CHATTEM SANOFI | |||||||
| ZANTAC 75 | RANITIDINE HYDROCHLORIDE | TABLET, EFFERVESCENT;ORAL | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA020707 - SANOFI AVENTIS US | |||||||
| SKELID | TILUDRONATE DISODIUM | TABLET;ORAL | EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA020625 - CHATTEM SANOFI | |||||||
| ALLEGRA | FEXOFENADINE HYDROCHLORIDE | CAPSULE;ORAL | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA020579 - SANOFI | |||||||
| FLOMAX | TAMSULOSIN HYDROCHLORIDE | CAPSULE;ORAL | 0.4MG | Prescription | |||
| NDA020520 - CHATTEM SANOFI | |||||||
| ZANTAC 75 | RANITIDINE HYDROCHLORIDE | TABLET;ORAL | EQ 75MG BASE | Discontinued | |||
| NDA020496 - SANOFI AVENTIS US | |||||||
| AMARYL | GLIMEPIRIDE | TABLET;ORAL | 2MG | Prescription | |||
| AMARYL | GLIMEPIRIDE | TABLET;ORAL | 4MG | Prescription | |||
| AMARYL | GLIMEPIRIDE | TABLET;ORAL | 1MG | Prescription | |||
| NDA020468 - CHATTEM SANOFI | |||||||
| NASACORT ALLERGY 24 HOUR | TRIAMCINOLONE ACETONIDE | SPRAY, METERED;NASAL | 0.055MG/SPRAY | Over-the-counter | |||
| NDA020449 - SANOFI AVENTIS US | |||||||
| TAXOTERE | DOCETAXEL | INJECTABLE;INJECTION | 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| TAXOTERE | DOCETAXEL | INJECTABLE;INJECTION | 20MG/ML (20MG/ML) | Prescription | |||
| TAXOTERE | DOCETAXEL | INJECTABLE;INJECTION | 80MG/4ML (20MG/ML) | Prescription | |||
| TAXOTERE | DOCETAXEL | INJECTABLE;INJECTION | 160MG/8ML (20MG/ML) | Prescription | |||
| NDA020343 - SANOFI AVENTIS US | |||||||
| PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | MILRINONE LACTATE | INJECTABLE;INJECTION | EQ 10MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | MILRINONE LACTATE | INJECTABLE;INJECTION | EQ 15MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | MILRINONE LACTATE | INJECTABLE;INJECTION | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | MILRINONE LACTATE | INJECTABLE;INJECTION | EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA020165 - CHATTEM SANOFI | |||||||
| NICODERM CQ | NICOTINE | FILM, EXTENDED RELEASE;TRANSDERMAL | 7MG/24HR | Over-the-counter | |||
| NICODERM CQ | NICOTINE | FILM, EXTENDED RELEASE;TRANSDERMAL | 14MG/24HR | Over-the-counter | |||
| NICODERM CQ | NICOTINE | FILM, EXTENDED RELEASE;TRANSDERMAL | 21MG/24HR | Over-the-counter | |||
| NDA020164 - SANOFI AVENTIS US | |||||||
| LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 40MG/0.4ML (100MG/ML) | Prescription | |||
| LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 60MG/0.6ML (100MG/ML) | Prescription | |||
| LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 90MG/0.6ML (150MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 120MG/0.8ML (150MG/ML) | Prescription | |||
| LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 150MG/ML (150MG/ML) | Prescription | |||
| LOVENOX | ENOXAPARIN SODIUM | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 300MG/3ML (100MG/ML) | Prescription | |||
| LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 80MG/0.8ML (100MG/ML) | Prescription | |||
| LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 100MG/ML (100MG/ML) | Prescription | |||
| LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 30MG/0.3ML (100MG/ML) | Prescription | |||
| NDA020055 - SANOFI AVENTIS US | |||||||
| GLYBURIDE (MICRONIZED) | GLYBURIDE | TABLET;ORAL | 3MG | Discontinued | |||
| GLYBURIDE (MICRONIZED) | GLYBURIDE | TABLET;ORAL | 6MG | Discontinued | |||
| GLYBURIDE (MICRONIZED) | GLYBURIDE | TABLET;ORAL | 1.5MG | Discontinued | |||
| NDA019908 - SANOFI AVENTIS US | |||||||
| AMBIEN | ZOLPIDEM TARTRATE | TABLET;ORAL | 10MG | Prescription | |||
| AMBIEN | ZOLPIDEM TARTRATE | TABLET;ORAL | 5MG | Prescription | |||
| NDA019879 - SANOFI AVENTIS US | |||||||
| ORNIDYL | EFLORNITHINE HYDROCHLORIDE | INJECTABLE;INJECTION | 200MG/ML | Discontinued | |||
| NDA019807 - SANOFI AVENTIS US | |||||||
| KERLEDEX | BETAXOLOL HYDROCHLORIDE; CHLORTHALIDONE | TABLET;ORAL | 5MG;12.5MG | Discontinued | |||
| KERLEDEX | BETAXOLOL HYDROCHLORIDE; CHLORTHALIDONE | TABLET;ORAL | 10MG;12.5MG | Discontinued | |||
| NDA019798 - CHATTEM SANOFI | |||||||
| NASACORT | TRIAMCINOLONE ACETONIDE | AEROSOL, METERED;NASAL | 0.055MG/INH | Discontinued | |||
| NDA019616 - SANOFI AVENTIS US | |||||||
| PENETREX | ENOXACIN | TABLET;ORAL | 400MG | Discontinued | |||
| PENETREX | ENOXACIN | TABLET;ORAL | 200MG | Discontinued | |||
| NDA019548 - SANOFI AVENTIS US | |||||||
| TORNALATE | BITOLTEROL MESYLATE | SOLUTION;INHALATION | 0.2% | Discontinued | |||
| NDA019507 - SANOFI AVENTIS US | |||||||
| KERLONE | BETAXOLOL HYDROCHLORIDE | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| KERLONE | BETAXOLOL HYDROCHLORIDE | TABLET;ORAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA019498 - SANOFI AVENTIS US | |||||||
| PARATHAR | TERIPARATIDE ACETATE | INJECTABLE;INJECTION | 200 UNITS/VIAL | Discontinued | |||
| NDA019436 - SANOFI AVENTIS US | |||||||
| PRIMACOR | MILRINONE LACTATE | INJECTABLE;INJECTION | EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA018770 - SANOFI AVENTIS US | |||||||
| TORNALATE | BITOLTEROL MESYLATE | AEROSOL, METERED;INHALATION | 0.37MG/INH | Discontinued | |||
| NDA018733 - SANOFI AVENTIS US | |||||||
| TALWIN NX | NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE | TABLET;ORAL | EQ 0.5MG BASE;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA018700 - SANOFI AVENTIS US | |||||||
| INOCOR | INAMRINONE LACTATE | INJECTABLE;INJECTION | EQ 5MG BASE/ML | Discontinued | |||
| NDA018685 - CHATTEM SANOFI | |||||||
| GAVISCON | ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE | TABLET, CHEWABLE;ORAL | 80MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| GAVISCON | ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE | TABLET, CHEWABLE;ORAL | 160MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA018621 - SANOFI AVENTIS US | |||||||
| NITRO-BID | NITROGLYCERIN | INJECTABLE;INJECTION | 5MG/ML | Discontinued | |||
| NDA018538 - SANOFI AVENTIS US | |||||||
| LOZOL | INDAPAMIDE | TABLET;ORAL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| LOZOL | INDAPAMIDE | TABLET;ORAL | 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA018458 - SANOFI AVENTIS US | |||||||
| TALACEN | ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE | TABLET;ORAL | 650MG;EQ 25MG BASE | Discontinued | |||
| NDA018237 - SANOFI AVENTIS US | |||||||
| CALCIPARINE | HEPARIN CALCIUM | INJECTABLE;INJECTION | 25,000 UNITS/ML | Discontinued | |||
| NDA018000 - SANOFI AVENTIS US | |||||||
| BRICANYL | TERBUTALINE SULFATE | AEROSOL, METERED;INHALATION | 0.2MG/INH | Discontinued | |||
| NDA017884 - SANOFI AVENTIS US | |||||||
| CHRONULAC | LACTULOSE | SOLUTION;ORAL | 10GM/15ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA017796 - SANOFI AVENTIS US | |||||||
| BRYREL | PIPERAZINE CITRATE | SYRUP;ORAL | EQ 500MG BASE/5ML | Discontinued | |||
| NDA017769 - SANOFI AVENTIS US | |||||||
| CALCIMAR | CALCITONIN SALMON | INJECTABLE;INJECTION | 200 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA017688 - SANOFI AVENTIS US | |||||||
| LASIX | FUROSEMIDE | SOLUTION;ORAL | 10MG/ML | Discontinued | |||
| NDA017669 - SANOFI AVENTIS US | |||||||
| TENUATE | DIETHYLPROPION HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 75MG | Discontinued | |||
| NDA017668 - SANOFI AVENTIS US | |||||||
| TENUATE | DIETHYLPROPION HYDROCHLORIDE | TABLET;ORAL | 25MG | Discontinued | |||
| NDA017657 - SANOFI AVENTIS US | |||||||
| CEPHULAC | LACTULOSE | SOLUTION;ORAL, RECTAL | 10GM/15ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA017618 - SANOFI AVENTIS US | |||||||
| BRICANYL | TERBUTALINE SULFATE | TABLET;ORAL | 5MG | Discontinued | |||
| BRICANYL | TERBUTALINE SULFATE | TABLET;ORAL | 2.5MG | Discontinued | |||
| NDA017603 - SANOFI AVENTIS US | |||||||
| NOVAFED | PSEUDOEPHEDRINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 120MG | Discontinued | |||
| NDA017557 - SANOFI AVENTIS US | |||||||
| DANOCRINE | DANAZOL | CAPSULE;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| DANOCRINE | DANAZOL | CAPSULE;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| DANOCRINE | DANAZOL | CAPSULE;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA017535 - SANOFI AVENTIS US | |||||||
| LORELCO | PROBUCOL | TABLET;ORAL | 250MG | Discontinued | |||
| LORELCO | PROBUCOL | TABLET;ORAL | 500MG | Discontinued | |||
| NDA017532 - SANOFI AVENTIS US | |||||||
| DIABETA | GLYBURIDE | TABLET;ORAL | 2.5MG | Prescription | |||
| DIABETA | GLYBURIDE | TABLET;ORAL | 5MG | Prescription | |||
| DIABETA | GLYBURIDE | TABLET;ORAL | 1.25MG | Prescription | |||
| NDA017497 - SANOFI AVENTIS US | |||||||
| CALCIMAR | CALCITONIN SALMON | INJECTABLE;INJECTION | 400 IU/VIAL | Discontinued | |||
| NDA017466 - SANOFI AVENTIS US | |||||||
| BRICANYL | TERBUTALINE SULFATE | INJECTABLE;INJECTION | 1MG/ML | Discontinued | |||
| NDA017446 - SANOFI AVENTIS US | |||||||
| PHISO-SCRUB | HEXACHLOROPHENE | SPONGE;TOPICAL | 3% | Discontinued | |||
| NDA017430 - SANOFI AVENTIS US | |||||||
| NEGGRAM | NALIDIXIC ACID | SUSPENSION;ORAL | 250MG/5ML | Discontinued | |||
| NDA016990 - SANOFI AVENTIS US | |||||||
| INTAL | CROMOLYN SODIUM | CAPSULE;INHALATION | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA016891 - SANOFI AVENTIS US | |||||||
| TALWIN COMPOUND | ASPIRIN; PENTAZOCINE HYDROCHLORIDE | TABLET;ORAL | 325MG;EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA016830 - SANOFI AVENTIS US | |||||||
| TRICLOS | TRICLOFOS SODIUM | SOLUTION;ORAL | 1.5GM/15ML | Discontinued | |||
| NDA016809 - SANOFI AVENTIS US | |||||||
| TRICLOS | TRICLOFOS SODIUM | TABLET;ORAL | 750MG | Discontinued | |||
| NDA016732 - SANOFI AVENTIS US | |||||||
| TALWIN 50 | PENTAZOCINE HYDROCHLORIDE | TABLET;ORAL | EQ 50MG BASE | Discontinued | |||
| NDA016363 - SANOFI AVENTIS US | |||||||
| LASIX | FUROSEMIDE | INJECTABLE;INJECTION | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA016235 - SANOFI AVENTIS US | |||||||
| TACE | CHLOROTRIANISENE | CAPSULE;ORAL | 72MG | Discontinued | |||
| NDA016131 - SANOFI AVENTIS US | |||||||
| CLOMID | CLOMIPHENE CITRATE | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA015103 - SANOFI AVENTIS US | |||||||
| REGROTON | CHLORTHALIDONE; RESERPINE | TABLET;ORAL | 50MG;0.25MG | Discontinued | |||
| DEMI-REGROTON | CHLORTHALIDONE; RESERPINE | TABLET;ORAL | 25MG;0.125MG | Discontinued | |||
| NDA014860 - SANOFI AVENTIS US | |||||||
| ARALEN PHOSPHATE W/ PRIMAQUINE PHOSPHATE | CHLOROQUINE PHOSPHATE; PRIMAQUINE PHOSPHATE | TABLET;ORAL | EQ 300MG BASE;EQ 45MG BASE | Discontinued | |||
| NDA014214 - SANOFI AVENTIS US | |||||||
| NEGGRAM | NALIDIXIC ACID | TABLET;ORAL | 500MG | Discontinued | |||
| NEGGRAM | NALIDIXIC ACID | TABLET;ORAL | 250MG | Discontinued | |||
| NEGGRAM | NALIDIXIC ACID | TABLET;ORAL | 1GM | Discontinued | |||
| NDA013621 - SANOFI AVENTIS US | |||||||
| PERTOFRANE | DESIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 25MG | Discontinued | |||
| PERTOFRANE | DESIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 50MG | Discontinued | |||
| NDA012972 - SANOFI AVENTIS US | |||||||
| METATENSIN #2 | RESERPINE; TRICHLORMETHIAZIDE | TABLET;ORAL | 0.1MG;2MG | Discontinued | |||
| METATENSIN #4 | RESERPINE; TRICHLORMETHIAZIDE | TABLET;ORAL | 0.1MG;4MG | Discontinued | |||
| NDA012594 - SANOFI AVENTIS US | |||||||
| METAHYDRIN | TRICHLORMETHIAZIDE | TABLET;ORAL | 2MG | Discontinued | |||
| METAHYDRIN | TRICHLORMETHIAZIDE | TABLET;ORAL | 4MG | Discontinued | |||
| NDA012339 - SANOFI AVENTIS US | |||||||
| BRONKOMETER | ISOETHARINE MESYLATE | AEROSOL, METERED;INHALATION | 0.34MG/INH | Discontinued | |||
| BRONKOSOL | ISOETHARINE HYDROCHLORIDE | SOLUTION;INHALATION | 1% | Discontinued | |||
| BRONKOSOL | ISOETHARINE HYDROCHLORIDE | SOLUTION;INHALATION | 0.25% | Discontinued | |||
| NDA012283 - SANOFI AVENTIS US | |||||||
| HYGROTON | CHLORTHALIDONE | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| HYGROTON | CHLORTHALIDONE | TABLET;ORAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA011836 - SANOFI AVENTIS US | |||||||
| PRESAMINE | IMIPRAMINE HYDROCHLORIDE | TABLET;ORAL | 25MG | Discontinued | |||
| PRESAMINE | IMIPRAMINE HYDROCHLORIDE | TABLET;ORAL | 10MG | Discontinued | |||
| PRESAMINE | IMIPRAMINE HYDROCHLORIDE | TABLET;ORAL | 50MG | Discontinued | |||
| NDA011467 - SANOFI AVENTIS US | |||||||
| TRANCOPAL | CHLORMEZANONE | TABLET;ORAL | 100MG | Discontinued | |||
| TRANCOPAL | CHLORMEZANONE | TABLET;ORAL | 200MG | Discontinued | |||
| NDA011444 - SANOFI AVENTIS US | |||||||
| TACE | CHLOROTRIANISENE | CAPSULE;ORAL | 25MG | Discontinued | |||
| NDA011178 - SANOFI AVENTIS US | |||||||
| ISUPREL | ISOPROTERENOL HYDROCHLORIDE | AEROSOL, METERED;INHALATION | 0.103MG/INH | Discontinued | |||
| NDA010787 - SANOFI AVENTIS US | |||||||
| IRON DEXTRAN | FERRIC OXYHYDROXIDE | INJECTABLE;INJECTION | EQ 50MG IRON/ML | Discontinued | |||
| NDA010679 - SANOFI AVENTIS US | |||||||
| CANTIL | MEPENZOLATE BROMIDE | TABLET;ORAL | 25MG | Discontinued | |||
| CANTIL | MEPENZOLATE BROMIDE | SOLUTION;ORAL | 25MG/5ML | Discontinued | |||
| NDA010598 - SANOFI AVENTIS US | |||||||
| BENDECTIN | DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 10MG;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA010155 - SANOFI AVENTIS US | |||||||
| MYTELASE | AMBENONIUM CHLORIDE | TABLET;ORAL | 10MG | Discontinued | |||
| NDA009519 - SANOFI AVENTIS US | |||||||
| DORIDEN | GLUTETHIMIDE | TABLET;ORAL | 250MG | Discontinued | |||
| DORIDEN | GLUTETHIMIDE | TABLET;ORAL | 500MG | Discontinued | |||
| DORIDEN | GLUTETHIMIDE | CAPSULE;ORAL | 500MG | Discontinued | |||
| NDA009410 - SANOFI AVENTIS US | |||||||
| LOTUSATE | TALBUTAL | TABLET;ORAL | 120MG | Discontinued | |||
| NDA009166 - SANOFI AVENTIS US | |||||||
| HYDROXYSTILBAMIDINE ISETHIONATE | HYDROXYSTILBAMIDINE ISETHIONATE | INJECTABLE;INJECTION | 225MG/AMP | Discontinued | |||
| NDA008767 - SANOFI AVENTIS US | |||||||
| HEDULIN | PHENINDIONE | TABLET;ORAL | 50MG | Discontinued | |||
| NDA008402 - SANOFI AVENTIS US | |||||||
| PHISOHEX | HEXACHLOROPHENE | EMULSION;TOPICAL | 3% | Discontinued | |||
| NDA008316 - SANOFI AVENTIS US | |||||||
| PRIMAQUINE | PRIMAQUINE PHOSPHATE | TABLET;ORAL | EQ 15MG BASE | Prescription | |||
| NDA008102 - SANOFI AVENTIS US | |||||||
| TACE | CHLOROTRIANISENE | CAPSULE;ORAL | 12MG | Discontinued | |||
| NDA007504 - SANOFI AVENTIS US | |||||||
| ACTHAR | CORTICOTROPIN | INJECTABLE;INJECTION | 40 UNITS/VIAL | Discontinued | |||
| ACTHAR | CORTICOTROPIN | INJECTABLE;INJECTION | 25 UNITS/VIAL | Discontinued | |||
| NDA006882 - SANOFI AVENTIS US | |||||||
| PHISOHEX | HEXACHLOROPHENE | EMULSION;TOPICAL | 3% | Discontinued | |||
| NDA006412 - SANOFI AVENTIS US | |||||||
| DECAPRYN | DOXYLAMINE SUCCINATE | TABLET;ORAL | 25MG | Discontinued | |||
| DECAPRYN | DOXYLAMINE SUCCINATE | TABLET;ORAL | 12.5MG | Discontinued | |||
| NDA006328 - SANOFI AVENTIS US | |||||||
| ISUPREL | ISOPROTERENOL HYDROCHLORIDE | TABLET;RECTAL, SUBLINGUAL | 10MG | Discontinued | |||
| ISUPREL | ISOPROTERENOL HYDROCHLORIDE | TABLET;RECTAL, SUBLINGUAL | 15MG | Discontinued | |||
| NDA006327 - SANOFI AVENTIS US | |||||||
| ISUPREL | ISOPROTERENOL HYDROCHLORIDE | SOLUTION;INHALATION | 0.5% | Discontinued | |||
| ISUPREL | ISOPROTERENOL HYDROCHLORIDE | SOLUTION;INHALATION | 1% | Discontinued | |||
| NDA006002 - SANOFI AVENTIS US | |||||||
| ARALEN | CHLOROQUINE PHOSPHATE | TABLET;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ARALEN HYDROCHLORIDE | CHLOROQUINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 40MG BASE/ML | Discontinued | |||