FDA Approved Products

Application #	Type	Sponsor	Product #	Drug Name	Form	Strength	Active Ingredient	Approval Date	Marketing Status	Reference Standard
218436	NDA	NOVARTIS PHARMS CORP	001	RHAPSIDO	TABLET;ORAL	25MG	REMIBRUTINIB	2025-09-30	Prescription	No
219208	NDA	NOVARTIS	001	VANRAFIA	TABLET;ORAL	EQ 0.75MG BASE	ATRASENTAN HYDROCHLORIDE	2025-04-02	Prescription	Yes
218466	NDA	NOVARTIS	001	VIJOICE	GRANULES;ORAL	50MG/PACKET	ALPELISIB	2024-04-24	Prescription	Yes
218591	NDA	NOVARTIS	001	ENTRESTO SPRINKLE	CAPSULE, PELLETS;ORAL	6MG;6MG	SACUBITRIL; VALSARTAN	2024-04-12	Prescription	No
218591	NDA	NOVARTIS	002	ENTRESTO SPRINKLE	CAPSULE, PELLETS;ORAL	15MG;16MG	SACUBITRIL; VALSARTAN	2024-04-12	Prescription	Yes
218276	NDA	NOVARTIS	001	FABHALTA	CAPSULE;ORAL	EQ 200MG BASE	IPTACOPAN HYDROCHLORIDE	2023-12-05	Prescription	Yes
761349	BLA	NOVARTIS PHARMS CORP	001	COSENTYX	INJECTABLE;INJECTION	150MG	SECUKINUMAB	2023-10-06	Prescription	No
217513	NDA	NOVARTIS	001	MEKINIST	SOLUTION;ORAL	EQ 0.05MG BASE/ML	TRAMETINIB DIMETHYL SULFOXIDE	2023-03-16	Prescription	Yes
			002	MEKINIST	TABLET;ORAL	2MG	TRAMETINIB	2023-03-16	Prescription	No
			003	MEKINIST	SOLUTION;ORAL	4.7MG	TRAMETINIB	2023-03-16	Prescription	No
217514	NDA	NOVARTIS	001	TAFINLAR	TABLET, FOR SUSPENSION;ORAL	EQ 10MG BASE	DABRAFENIB MESYLATE	2023-03-16	Prescription	Yes
			002	TAFINLAR	CAPSULE;ORAL	75MG	DABRAFENIB MESYLATE	2023-03-16	Prescription	No
			003	TAFINLAR	TABLET; ORAL SUSPENSION	10MG	DABRAFENIB MESYLATE	2023-03-16	Prescription	No
215039	NDA	NOVARTIS	001	VIJOICE	TABLET;ORAL	50MG	ALPELISIB	2022-04-05	Prescription	No
			002	VIJOICE	TABLET;ORAL	125MG	ALPELISIB	2022-04-05	Prescription	No
			003	VIJOICE	TABLET;ORAL	200MG	ALPELISIB	2022-04-05	Prescription	Yes
215833	NDA	NOVARTIS	001	PLUVICTO	SOLUTION;INTRAVENOUS	27mCi/ML	LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN	2022-03-23	Prescription	Yes
215841	NDA	NOVARTIS	001	LOCAMETZ	POWDER;INTRAVENOUS	N/A	GALLIUM GA-68 GOZETOTIDE	2022-03-23	Prescription	Yes
214012	NDA	NOVARTIS	001	LEQVIO	SOLUTION;SUBCUTANEOUS	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	INCLISIRAN SODIUM	2021-12-22	Prescription	Yes
215358	NDA	NOVARTIS	001	SCEMBLIX	TABLET;ORAL	EQ 20MG BASE	ASCIMINIB HYDROCHLORIDE	2021-10-29	Prescription	No
			002	SCEMBLIX	TABLET;ORAL	EQ 40MG BASE	ASCIMINIB HYDROCHLORIDE	2021-10-29	Prescription	Yes
			003	SCEMBLIX	TABLET;ORAL	EQ 100MG BASE	ASCIMINIB HYDROCHLORIDE	2021-10-29	Prescription	No
213591	NDA	NOVARTIS PHARM	001	TABRECTA	TABLET;ORAL	EQ 150MG BASE	CAPMATINIB HYDROCHLORIDE	2020-05-06	Prescription	No
213591	NDA	NOVARTIS PHARM	002	TABRECTA	TABLET;ORAL	EQ 200MG BASE	CAPMATINIB HYDROCHLORIDE	2020-05-06	Prescription	Yes
761128	BLA	NOVARTIS PHARMS CORP	001	ADAKVEO	INJECTABLE; INJECTION	100MG/10ML	CRIZANLIZUMAB-TMCA	2019-11-15	Prescription	No
761125	BLA	NOVARTIS PHARMS CORP	001	BEOVU	INJECTABLE; INTRAVITREAL	6MG/0.05ML	brolucizumab-dbll	2019-10-07	Prescription	No
212526	NDA	NOVARTIS	001	PIQRAY	TABLET;ORAL	50MG	ALPELISIB	2019-05-24	Prescription	No
			002	PIQRAY	TABLET;ORAL	150MG	ALPELISIB	2019-05-24	Prescription	No
			003	PIQRAY	TABLET;ORAL	200MG	ALPELISIB	2019-05-24	Prescription	Yes
209884	NDA	NOVARTIS	001	MAYZENT	TABLET;ORAL	EQ 0.25MG BASE	SIPONIMOD	2019-03-26	Prescription	No
			002	MAYZENT	TABLET;ORAL	EQ 2MG BASE	SIPONIMOD	2019-03-26	Prescription	Yes
			003	MAYZENT	TABLET;ORAL	EQ 1MG BASE	SIPONIMOD	2019-03-26	Prescription	No
211225	NDA	NOVARTIS	001	ZYKADIA	TABLET;ORAL	150MG	CERITINIB	2019-03-18	Prescription	Yes
208711	NDA	NOVARTIS	001	EGATEN	TABLET;ORAL	250MG	TRICLABENDAZOLE	2019-02-13	Prescription	Yes
207968	NDA	NOVARTIS	001	JADENU SPRINKLE	GRANULE;ORAL	90MG	DEFERASIROX	2017-05-18	Prescription	No
			002	JADENU SPRINKLE	GRANULE;ORAL	180MG	DEFERASIROX	2017-05-18	Prescription	No
			003	JADENU SPRINKLE	GRANULE;ORAL	360MG	DEFERASIROX	2017-05-18	Prescription	Yes
209935	NDA	NOVARTIS	001	KISQALI FEMARA CO-PACK (COPACKAGED)	TABLET;ORAL	2.5MG;EQ 200MG BASE	LETROZOLE; RIBOCICLIB SUCCINATE	2017-05-04	Prescription	Yes
207997	NDA	NOVARTIS	001	RYDAPT	CAPSULE;ORAL	25MG	MIDOSTAURIN	2017-04-28	Prescription	Yes
209092	NDA	NOVARTIS	001	KISQALI	TABLET;ORAL	EQ 200MG BASE	RIBOCICLIB SUCCINATE	2017-03-13	Prescription	Yes
207923	NDA	NOVARTIS	001	SEEBRI NEOHALER	POWDER;INHALATION	15.6MCG/INH	GLYCOPYRROLATE	2015-10-29	Discontinued	No
207930	NDA	NOVARTIS	001	UTIBRON NEOHALER	POWDER;INHALATION	15.6MCG/INH;27.5MCG/INH	GLYCOPYRROLATE; INDACATEROL MALEATE	2015-10-29	Discontinued	No
207027	NDA	NOVARTIS	001	PROMACTA KIT	FOR SUSPENSION;ORAL	EQ 25MG ACID/PACKET	ELTROMBOPAG OLAMINE	2015-08-24	Prescription	Yes
207027	NDA	NOVARTIS	002	PROMACTA KIT	FOR SUSPENSION;ORAL	EQ 12.5MG ACID/PACKET	ELTROMBOPAG OLAMINE	2015-08-24	Prescription	No
207620	NDA	NOVARTIS PHARMS CORP	001	ENTRESTO	TABLET;ORAL	24MG;26MG	SACUBITRIL; VALSARTAN	2015-07-07	Prescription	No
			002	ENTRESTO	TABLET;ORAL	49MG;51MG	SACUBITRIL; VALSARTAN	2015-07-07	Prescription	No
			003	ENTRESTO	TABLET;ORAL	97MG;103MG	SACUBITRIL; VALSARTAN	2015-07-07	Prescription	Yes
206910	NDA	NOVARTIS PHARMS CORP	001	JADENU	TABLET;ORAL	90MG	DEFERASIROX	2015-03-30	Prescription	No
			002	JADENU	TABLET;ORAL	180MG	DEFERASIROX	2015-03-30	Prescription	No
			003	JADENU	TABLET;ORAL	360MG	DEFERASIROX	2015-03-30	Prescription	Yes
125504	BLA	NOVARTIS PHARMS CORP	001	COSENTYX	INJECTABLE;INJECTION	150MG/ML	SECUKINUMAB	2015-01-21	Prescription	No
204822	NDA	NOVARTIS	001	IZBA	SOLUTION/DROPS;OPHTHALMIC	0.003% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TRAVOPROST	2014-05-15	Discontinued	No
205755	NDA	NOVARTIS	001	ZYKADIA	CAPSULE;ORAL	150MG	CERITINIB	2014-04-29	Discontinued	No
202806	NDA	NOVARTIS	001	TAFINLAR	CAPSULE;ORAL	EQ 50MG BASE	DABRAFENIB MESYLATE	2013-05-29	Prescription	No
202806	NDA	NOVARTIS	002	TAFINLAR	CAPSULE;ORAL	EQ 75MG BASE	DABRAFENIB MESYLATE	2013-05-29	Prescription	Yes
204114	NDA	NOVARTIS	001	MEKINIST	TABLET;ORAL	EQ 0.5MG	TRAMETINIB DIMETHYL SULFOXIDE	2013-05-29	Prescription	No
			002	MEKINIST	TABLET;ORAL	EQ 1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TRAMETINIB DIMETHYL SULFOXIDE	2013-05-29	Discontinued	No
			003	MEKINIST	TABLET;ORAL	EQ 2MG	TRAMETINIB DIMETHYL SULFOXIDE	2013-05-29	Prescription	Yes
203985	NDA	NOVARTIS PHARM	001	AFINITOR DISPERZ	TABLET, FOR SUSPENSION;ORAL	2MG	EVEROLIMUS	2012-08-29	Prescription	No
			002	AFINITOR DISPERZ	TABLET, FOR SUSPENSION;ORAL	3MG	EVEROLIMUS	2012-08-29	Prescription	No
			003	AFINITOR DISPERZ	TABLET, FOR SUSPENSION;ORAL	5MG	EVEROLIMUS	2012-08-29	Prescription	Yes
022383	NDA	NOVARTIS	001	ARCAPTA NEOHALER	POWDER;INHALATION	EQ 75MCG BASE	INDACATEROL MALEATE	2011-07-01	Discontinued	No
200045	NDA	NOVARTIS	001	AMTURNIDE	TABLET;ORAL	EQ 150MG BASE;EQ 5MG BASE;12.5MG	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE	2010-12-21	Discontinued	No
			002	AMTURNIDE	TABLET;ORAL	EQ 300MG BASE;EQ 5MG BASE;12.5MG	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE	2010-12-21	Discontinued	No
			003	AMTURNIDE	TABLET;ORAL	EQ 300MG BASE;EQ 5MG BASE;25MG	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE	2010-12-21	Discontinued	No
			004	AMTURNIDE	TABLET;ORAL	EQ 300MG BASE;EQ 10MG BASE;12.5MG	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE	2010-12-21	Discontinued	No
			005	AMTURNIDE	TABLET;ORAL	EQ 300MG BASE;EQ 10MG BASE;25MG	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE	2010-12-21	Discontinued	No
022527	NDA	NOVARTIS	001	GILENYA	CAPSULE;ORAL	EQ 0.5MG BASE	FINGOLIMOD HYDROCHLORIDE	2010-09-21	Prescription	Yes
022527	NDA	NOVARTIS	002	GILENYA	CAPSULE;ORAL	EQ 0.25MG BASE	FINGOLIMOD HYDROCHLORIDE	2010-09-21	Prescription	No
022545	NDA	NOVARTIS	001	TEKAMLO	TABLET;ORAL	EQ 150MG BASE;EQ 5MG BASE	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE	2010-08-26	Discontinued	No
			002	TEKAMLO	TABLET;ORAL	EQ 150MG BASE;EQ 10MG BASE	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE	2010-08-26	Discontinued	No
			003	TEKAMLO	TABLET;ORAL	EQ 300MG BASE;EQ 5MG BASE	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE	2010-08-26	Discontinued	No
			004	TEKAMLO	TABLET;ORAL	EQ 300MG BASE;EQ 10MG BASE	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE	2010-08-26	Discontinued	No
021560	NDA	NOVARTIS	001	ZORTRESS	TABLET;ORAL	0.25MG	EVEROLIMUS	2010-04-20	Prescription	No
			002	ZORTRESS	TABLET;ORAL	0.5MG	EVEROLIMUS	2010-04-20	Prescription	No
			003	ZORTRESS	TABLET;ORAL	0.75MG	EVEROLIMUS	2010-04-20	Prescription	No
			004	ZORTRESS	TABLET;ORAL	1MG	EVEROLIMUS	2010-04-20	Prescription	Yes
022470	NDA	NOVARTIS	001	NEXCEDE	FILM;ORAL	12.5MG	KETOPROFEN	2009-11-25	Discontinued	No
125326	BLA	NOVARTIS	001	ARZERRA	INJECTABLE; INJECTION	100MG/5ML	OFATUMUMAB	2009-10-26	Prescription	No
125326	BLA	NOVARTIS	002	KESIMPTA	SOLUTION;SUBCUTANEOUS	20MG/0.4ML	OFATUMUMAB	2009-10-26	Prescription	No
022465	NDA	NOVARTIS	001	VOTRIENT	TABLET;ORAL	EQ 200MG BASE	PAZOPANIB HYDROCHLORIDE	2009-10-19	Prescription	Yes
022465	NDA	NOVARTIS	002	VOTRIENT	TABLET;ORAL	EQ 400MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PAZOPANIB HYDROCHLORIDE	2009-10-19	Discontinued	No
022217	NDA	NOVARTIS	001	VALTURNA	TABLET;ORAL	EQ 150MG BASE;160MG	ALISKIREN HEMIFUMARATE; VALSARTAN	2009-09-16	Discontinued	No
022217	NDA	NOVARTIS	002	VALTURNA	TABLET;ORAL	EQ 300MG BASE;320MG	ALISKIREN HEMIFUMARATE; VALSARTAN	2009-09-16	Discontinued	No
125319	BLA	NOVARTIS PHARMS	001	ILARIS	INJECTABLE; SUBCUTANEOUS	180MG	CANAKINUMAB	2009-06-17	Prescription	No
022314	NDA	NOVARTIS	001	EXFORGE HCT	TABLET;ORAL	EQ 5MG BASE;12.5MG;160MG	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	2009-04-30	Prescription	No
			002	EXFORGE HCT	TABLET;ORAL	EQ 5MG BASE;25MG;160MG	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	2009-04-30	Prescription	No
			003	EXFORGE HCT	TABLET;ORAL	EQ 10MG BASE;12.5MG;160MG	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	2009-04-30	Prescription	No
			004	EXFORGE HCT	TABLET;ORAL	EQ 10MG BASE;25MG;160MG	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	2009-04-30	Prescription	No
			005	EXFORGE HCT	TABLET;ORAL	EQ 10MG BASE;25MG;320MG	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	2009-04-30	Prescription	Yes
022154	NDA	NOVARTIS	001	TYZEKA	SOLUTION;ORAL	100MG/5ML	TELBIVUDINE	2009-04-28	Discontinued	No
022268	NDA	NOVARTIS	001	COARTEM	TABLET;ORAL	20MG;120MG	ARTEMETHER; LUMEFANTRINE	2009-04-07	Prescription	Yes
022334	NDA	NOVARTIS	001	AFINITOR	TABLET;ORAL	5MG	EVEROLIMUS	2009-03-30	Prescription	Yes
			002	AFINITOR	TABLET;ORAL	10MG	EVEROLIMUS	2009-03-30	Prescription	No
			003	AFINITOR	TABLET;ORAL	2.5MG	EVEROLIMUS	2009-03-30	Prescription	No
			004	AFINITOR	TABLET;ORAL	7.5MG	EVEROLIMUS	2009-03-30	Prescription	No
022291	NDA	NOVARTIS	001	PROMACTA	TABLET;ORAL	EQ 25MG ACID	ELTROMBOPAG OLAMINE	2008-11-20	Prescription	No
			002	PROMACTA	TABLET;ORAL	EQ 50MG ACID	ELTROMBOPAG OLAMINE	2008-11-20	Prescription	No
			003	PROMACTA	TABLET;ORAL	EQ 75MG ACID	ELTROMBOPAG OLAMINE	2008-11-20	Prescription	Yes
			004	PROMACTA	TABLET;ORAL	EQ 12.5MG ACID	ELTROMBOPAG OLAMINE	2008-11-20	Prescription	No
			005	PROMACTA	TABLET;ORAL	EQ 100MG ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ELTROMBOPAG OLAMINE	2008-11-20	Discontinued	No
021861	NDA	NOVARTIS	001	PATANASE	SPRAY, METERED;NASAL	0.665MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OLOPATADINE HYDROCHLORIDE	2008-04-15	Discontinued	No
022068	NDA	NOVARTIS	001	TASIGNA	CAPSULE;ORAL	EQ 200MG BASE	NILOTINIB HYDROCHLORIDE	2007-10-29	Prescription	Yes
			002	TASIGNA	CAPSULE;ORAL	EQ 150MG BASE	NILOTINIB HYDROCHLORIDE	2007-10-29	Prescription	No
			003	TASIGNA	CAPSULE;ORAL	EQ 50MG BASE	NILOTINIB HYDROCHLORIDE	2007-10-29	Prescription	No
022071	NDA	NOVARTIS	001	LAMISIL	GRANULE;ORAL	EQ 125MG BASE/PACKET	TERBINAFINE HYDROCHLORIDE	2007-09-28	Discontinued	No
022071	NDA	NOVARTIS	002	LAMISIL	GRANULE;ORAL	EQ 187.5MG BASE/PACKET	TERBINAFINE HYDROCHLORIDE	2007-09-28	Discontinued	No
021990	NDA	NOVARTIS	002	EXFORGE	TABLET;ORAL	EQ 5MG BASE;160MG	AMLODIPINE BESYLATE; VALSARTAN	2007-06-20	Prescription	No
			003	EXFORGE	TABLET;ORAL	EQ 10MG BASE;160MG	AMLODIPINE BESYLATE; VALSARTAN	2007-06-20	Prescription	Yes
			004	EXFORGE	TABLET;ORAL	EQ 5MG BASE;320MG	AMLODIPINE BESYLATE; VALSARTAN	2007-06-20	Prescription	No
			005	EXFORGE	TABLET;ORAL	EQ 10MG BASE;320MG	AMLODIPINE BESYLATE; VALSARTAN	2007-06-20	Prescription	Yes
022059	NDA	NOVARTIS	001	TYKERB	TABLET;ORAL	EQ 250MG BASE	LAPATINIB DITOSYLATE	2007-03-13	Prescription	Yes
021592	NDA	NOVARTIS	001	FORADIL CERTIHALER	POWDER;INHALATION	0.0085MG/INH	FORMOTEROL FUMARATE	2006-12-15	Discontinued	No
022011	NDA	NOVARTIS	001	TYZEKA	TABLET;ORAL	600MG	TELBIVUDINE	2006-10-25	Discontinued	No
021882	NDA	NOVARTIS	001	EXJADE	TABLET, FOR SUSPENSION;ORAL	125MG	DEFERASIROX	2005-11-02	Prescription	No
			002	EXJADE	TABLET, FOR SUSPENSION;ORAL	250MG	DEFERASIROX	2005-11-02	Prescription	No
			003	EXJADE	TABLET, FOR SUSPENSION;ORAL	500MG	DEFERASIROX	2005-11-02	Prescription	Yes
050791	NDA	NOVARTIS	001	MYFORTIC	TABLET, DELAYED RELEASE;ORAL	EQ 180MG BASE	MYCOPHENOLATE SODIUM	2004-02-27	Prescription	No
050791	NDA	NOVARTIS	002	MYFORTIC	TABLET, DELAYED RELEASE;ORAL	EQ 360MG BASE	MYCOPHENOLATE SODIUM	2004-02-27	Prescription	Yes
021588	NDA	NOVARTIS	001	GLEEVEC	TABLET;ORAL	EQ 100MG BASE	IMATINIB MESYLATE	2003-04-18	Prescription	No
021588	NDA	NOVARTIS	002	GLEEVEC	TABLET;ORAL	EQ 400MG BASE	IMATINIB MESYLATE	2003-04-18	Prescription	Yes
021386	NDA	NOVARTIS	001	ZOMETA	INJECTABLE; IV (INFUSION)	EQ 4MG BASE/VIAL	ZOLEDRONIC ACID	2002-02-22	Prescription	No
021279	NDA	NOVARTIS	001	FORADIL	POWDER; INHALATION	0.012MG/INH	FORMOTEROL FUMARATE	2001-09-25	Discontinued	No
021223	NDA	NOVARTIS	001	ZOMETA	INJECTABLE;INTRAVENOUS	EQ 4MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ZOLEDRONIC ACID	2001-08-20	Discontinued	No
			002	ZOMETA	INJECTABLE;INTRAVENOUS	EQ 4MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ZOLEDRONIC ACID	2001-08-20	Discontinued	No
			003	ZOMETA	INJECTABLE;INTRAVENOUS	EQ 4MG BASE/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ZOLEDRONIC ACID	2001-08-20	Discontinued	No
021283	NDA	NOVARTIS	001	DIOVAN	TABLET;ORAL	80MG	VALSARTAN	2001-07-18	Prescription	No
			002	DIOVAN	TABLET;ORAL	160MG	VALSARTAN	2001-07-18	Prescription	No
			003	DIOVAN	TABLET;ORAL	320MG	VALSARTAN	2001-07-18	Prescription	Yes
			004	DIOVAN	TABLET;ORAL	40MG	VALSARTAN	2001-07-18	Prescription	No
021285	NDA	NOVARTIS	001	TRILEPTAL	SUSPENSION;ORAL	300MG/5ML	OXCARBAZEPINE	2001-05-25	Prescription	Yes
021335	NDA	NOVARTIS	001	GLEEVEC	CAPSULE;ORAL	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	IMATINIB MESYLATE	2001-05-10	Discontinued	No
021335	NDA	NOVARTIS	002	GLEEVEC	CAPSULE;ORAL	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	IMATINIB MESYLATE	2001-05-10	Discontinued	No
021082	NDA	NOVARTIS	001	TAVIST ALLERGY/SINUS/HEADACHE	TABLET;ORAL	500MG;EQ 0.25MG BASE;30MG	ACETAMINOPHEN; CLEMASTINE FUMARATE; PSEUDOEPHEDRINE HYDROCHLORIDE	2001-03-01	Discontinued	No
020831	NDA	NOVARTIS	001	FORADIL	POWDER;INHALATION	0.012MG/INH Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FORMOTEROL FUMARATE	2001-02-16	Discontinued	No
021204	NDA	NOVARTIS	001	STARLIX	TABLET;ORAL	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	NATEGLINIDE	2000-12-22	Discontinued	No
021204	NDA	NOVARTIS	002	STARLIX	TABLET;ORAL	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	NATEGLINIDE	2000-12-22	Discontinued	No
021167	NDA	NOVARTIS	001	VIVELLE	FILM, EXTENDED RELEASE; TRANSDERMAL	0.0375MG/24HR	ESTRADIOL	2000-08-16	Discontinued	No
			002	VIVELLE	FILM, EXTENDED RELEASE; TRANSDERMAL	0.05MG/24HR	ESTRADIOL	2000-08-16	Prescription	No
			003	VIVELLE	FILM, EXTENDED RELEASE; TRANSDERMAL	0.075MG/24HR	ESTRADIOL	2000-08-16	Discontinued	No
			004	VIVELLE	FILM, EXTENDED RELEASE; TRANSDERMAL	0.1MG/24HR	ESTRADIOL	2000-08-16	Prescription	No
			005	VIVELLE	FILM, EXTENDED RELEASE; TRANSDERMAL	0.025MG/24HR	ESTRADIOL	2000-08-16	Discontinued	No
020823	NDA	NOVARTIS	003	EXELON	CAPSULE;ORAL	EQ 1.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	RIVASTIGMINE TARTRATE	2000-04-21	Discontinued	No
			004	EXELON	CAPSULE;ORAL	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	RIVASTIGMINE TARTRATE	2000-04-21	Discontinued	No
			005	EXELON	CAPSULE;ORAL	EQ 4.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	RIVASTIGMINE TARTRATE	2000-04-21	Discontinued	No
			006	EXELON	CAPSULE;ORAL	EQ 6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	RIVASTIGMINE TARTRATE	2000-04-21	Discontinued	No
021025	NDA	NOVARTIS	001	EXELON	SOLUTION;ORAL	EQ 2MG BASE/ML	RIVASTIGMINE TARTRATE	2000-04-21	Discontinued	No
021014	NDA	NOVARTIS	001	TRILEPTAL	TABLET;ORAL	150MG	OXCARBAZEPINE	2000-01-14	Prescription	No
			002	TRILEPTAL	TABLET;ORAL	300MG	OXCARBAZEPINE	2000-01-14	Prescription	No
			003	TRILEPTAL	TABLET;ORAL	600MG	OXCARBAZEPINE	2000-01-14	Prescription	Yes
021008	NDA	NOVARTIS	001	SANDOSTATIN LAR	INJECTABLE;INJECTION	EQ 10MG BASE/VIAL	OCTREOTIDE ACETATE	1998-11-25	Prescription	No
			002	SANDOSTATIN LAR	INJECTABLE;INJECTION	EQ 20MG BASE/VIAL	OCTREOTIDE ACETATE	1998-11-25	Prescription	No
			003	SANDOSTATIN LAR	INJECTABLE;INJECTION	EQ 30MG BASE/VIAL	OCTREOTIDE ACETATE	1998-11-25	Prescription	Yes
020927	NDA	NOVARTIS	001	AREDIA	INJECTABLE; INJECTION	30MG/VIAL	PAMIDRONATE DISODIUM	1998-09-22	Prescription	No
			002	AREDIA	INJECTABLE;INJECTION	60MG/VIAL	PAMIDRONATE DISODIUM	1998-09-22	Prescription	No
			003	AREDIA	INJECTABLE; INJECTION	90MG/VIAL	PAMIDRONATE DISODIUM	1998-09-22	Prescription	No
020961	NDA	NOVARTIS	001	VITRAVENE PRESERVATIVE FREE	INJECTABLE;INJECTION	6.6MG/ML	FOMIVIRSEN SODIUM	1998-08-26	Discontinued	No
103764	BLA	NOVARTIS	001	SIMULECT	VIAL; SINGLE-USE	10MG	BASILIXIMAB	1998-05-12	Prescription	No
103764	BLA	NOVARTIS	002	SIMULECT	VIAL; SINGLE-USE	20MG	BASILIXIMAB	1998-05-12	Prescription	No
020818	NDA	NOVARTIS	001	DIOVAN HCT	TABLET;ORAL	12.5MG;80MG	HYDROCHLOROTHIAZIDE; VALSARTAN	1998-03-06	Prescription	No
			002	DIOVAN HCT	TABLET;ORAL	12.5MG;160MG	HYDROCHLOROTHIAZIDE; VALSARTAN	1998-03-06	Prescription	No
			003	DIOVAN HCT	TABLET;ORAL	25MG;160MG	HYDROCHLOROTHIAZIDE; VALSARTAN	1998-03-06	Prescription	No
			004	DIOVAN HCT	TABLET;ORAL	12.5MG;320MG	HYDROCHLOROTHIAZIDE; VALSARTAN	1998-03-06	Prescription	No
			005	DIOVAN HCT	TABLET;ORAL	25MG;320MG	HYDROCHLOROTHIAZIDE; VALSARTAN	1998-03-06	Prescription	Yes
020706	NDA	NOVARTIS	001	EMADINE	SOLUTION/DROPS;OPHTHALMIC	0.05%	EMEDASTINE DIFUMARATE	1997-12-29	Discontinued	No
020726	NDA	NOVARTIS PHARMS	001	FEMARA	TABLET;ORAL	2.5MG	LETROZOLE	1997-07-25	Prescription	Yes
008319	NDA	NOVARTIS	008	BUTAZOLIDIN	TABLET;ORAL	100MG	PHENYLBUTAZONE	1997-06-25	Discontinued	No
008319	NDA	NOVARTIS	009	BUTAZOLIDIN	CAPSULE;ORAL	100MG	PHENYLBUTAZONE	1997-06-25	Discontinued	No
050737	NDA	NOVARTIS	001	NEORAL	CAPSULE; ORAL	25MG	CYCLOSPORINE	1997-06-19	Prescription	No
050737	NDA	NOVARTIS	002	NEORAL	CAPSULE; ORAL	100MG	CYCLOSPORINE	1997-06-19	Prescription	No
050738	NDA	NOVARTIS	001	NEORAL	CAPSULE; ORAL	25MG	CYCLOSPORINE	1997-06-19	Prescription	No
050738	NDA	NOVARTIS	002	NEORAL	CAPSULE; ORAL	100MG	CYCLOSPORINE	1997-06-19	Prescription	No
050735	NDA	NOVARTIS	001	NEORAL	CAPSULE; ORAL	25MG	CYCLOSPORINE	1997-05-22	Prescription	No
050735	NDA	NOVARTIS	002	NEORAL	CAPSULE; ORAL	100MG	CYCLOSPORINE	1997-05-22	Prescription	No
050736	NDA	NOVARTIS	001	NEORAL	CAPSULE; ORAL	25MG	CYCLOSPORINE	1997-05-22	Prescription	No
050736	NDA	NOVARTIS	002	NEORAL	CAPSULE; ORAL	100MG	CYCLOSPORINE	1997-05-22	Prescription	No
020665	NDA	NOVARTIS	001	DIOVAN	CAPSULE;ORAL	80MG	VALSARTAN	1996-12-23	Discontinued	No
020665	NDA	NOVARTIS	002	DIOVAN	CAPSULE;ORAL	160MG	VALSARTAN	1996-12-23	Discontinued	No
020539	NDA	NOVARTIS	001	LAMISIL	TABLET;ORAL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TERBINAFINE HYDROCHLORIDE	1996-05-10	Discontinued	No
020234	NDA	NOVARTIS	001	TEGRETOL-XR	TABLET, EXTENDED RELEASE;ORAL	100MG	CARBAMAZEPINE	1996-03-25	Prescription	No
			002	TEGRETOL-XR	TABLET, EXTENDED RELEASE;ORAL	200MG	CARBAMAZEPINE	1996-03-25	Prescription	No
			003	TEGRETOL-XR	TABLET, EXTENDED RELEASE;ORAL	400MG	CARBAMAZEPINE	1996-03-25	Prescription	Yes
020254	NDA	NOVARTIS	001	VOLTAREN-XR	TABLET, EXTENDED RELEASE;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	DICLOFENAC SODIUM	1996-03-08	Discontinued	No
089047	ANDA	NOVARTIS	001	SULF-15	SOLUTION/DROPS;OPHTHALMIC	15%	SULFACETAMIDE SODIUM	1995-10-31	Discontinued	No
050715	NDA	NOVARTIS	001	NEORAL	CAPSULE;ORAL	25MG	CYCLOSPORINE	1995-07-14	Prescription	No
			002	NEORAL	CAPSULE;ORAL	100MG	CYCLOSPORINE	1995-07-14	Prescription	Yes
			003	NEORAL	CAPSULE;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CYCLOSPORINE	1995-07-14	Discontinued	No
050716	NDA	NOVARTIS	001	NEORAL	SOLUTION;ORAL	100MG/ML	CYCLOSPORINE	1995-07-14	Prescription	Yes
073677	ANDA	NOVARTIS	001	CARBASTAT	SOLUTION;INTRAOCULAR	0.01%	CARBACHOL	1995-04-28	Discontinued	No
020363	NDA	NOVARTIS	001	FAMVIR	TABLET;ORAL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FAMCICLOVIR	1994-06-29	Discontinued	No
			002	FAMVIR	TABLET;ORAL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FAMCICLOVIR	1994-06-29	Discontinued	No
			003	FAMVIR	TABLET;ORAL	125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FAMCICLOVIR	1994-06-29	Discontinued	No
020261	NDA	NOVARTIS	001	LESCOL	CAPSULE;ORAL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FLUVASTATIN SODIUM	1993-12-31	Discontinued	No
020261	NDA	NOVARTIS	002	LESCOL	CAPSULE;ORAL	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FLUVASTATIN SODIUM	1993-12-31	Discontinued	No
020142	NDA	NOVARTIS	001	CATAFLAM	TABLET;ORAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	DICLOFENAC POTASSIUM	1993-11-24	Discontinued	No
020142	NDA	NOVARTIS	002	CATAFLAM	TABLET;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	DICLOFENAC POTASSIUM	1993-11-24	Discontinued	No
020219	NDA	NOVARTIS	001	LIVOSTIN	SUSPENSION/DROPS;OPHTHALMIC	EQ 0.05% BASE	LEVOCABASTINE HYDROCHLORIDE	1993-11-10	Discontinued	No
020191	NDA	NOVARTIS	001	ALOMIDE	SOLUTION/DROPS;OPHTHALMIC	EQ 0.1% BASE	LODOXAMIDE TROMETHAMINE	1993-09-23	Discontinued	No
020192	NDA	NOVARTIS	001	LAMISIL	CREAM;TOPICAL	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TERBINAFINE HYDROCHLORIDE	1992-12-30	Discontinued	No
020036	NDA	NOVARTIS	001	AREDIA	INJECTABLE;INJECTION	30MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PAMIDRONATE DISODIUM	1991-10-31	Discontinued	No
			003	AREDIA	INJECTABLE;INJECTION	60MG/VIAL	PAMIDRONATE DISODIUM	1991-10-31	Discontinued	No
			004	AREDIA	INJECTABLE;INJECTION	90MG/VIAL	PAMIDRONATE DISODIUM	1991-10-31	Discontinued	No
020037	NDA	NOVARTIS	001	VOLTAREN	SOLUTION/DROPS;OPHTHALMIC	0.1%	DICLOFENAC SODIUM	1991-03-28	Discontinued	No
019972	NDA	NOVARTIS	001	OCUPRESS	SOLUTION/DROPS;OPHTHALMIC	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CARTEOLOL HYDROCHLORIDE	1990-05-23	Discontinued	No
018746	NDA	NOVARTIS	002	VASOCON-A	SOLUTION/DROPS;OPHTHALMIC	0.5%;0.05%	ANTAZOLINE PHOSPHATE; NAPHAZOLINE HYDROCHLORIDE	1990-04-30	Discontinued	No
050625	NDA	NOVARTIS	001	SANDIMMUNE	CAPSULE;ORAL	25MG	CYCLOSPORINE	1990-03-02	Prescription	No
			002	SANDIMMUNE	CAPSULE;ORAL	100MG	CYCLOSPORINE	1990-03-02	Prescription	Yes
			003	SANDIMMUNE	CAPSULE;ORAL	50MG	CYCLOSPORINE	1990-03-02	Prescription	No
019845	NDA	NOVARTIS	001	BETOPTIC S	SUSPENSION/DROPS;OPHTHALMIC	EQ 0.25% BASE	BETAXOLOL HYDROCHLORIDE	1989-12-29	Prescription	Yes
019786	NDA	NOVARTIS	001	LOPRESSOR	TABLET, EXTENDED RELEASE;ORAL	EQ 100MG TARTRATE	METOPROLOL FUMARATE	1989-12-27	Discontinued	No
			002	LOPRESSOR	TABLET, EXTENDED RELEASE;ORAL	EQ 200MG TARTRATE	METOPROLOL FUMARATE	1989-12-27	Discontinued	No
			003	LOPRESSOR	TABLET, EXTENDED RELEASE;ORAL	EQ 300MG TARTRATE	METOPROLOL FUMARATE	1989-12-27	Discontinued	No
			004	LOPRESSOR	TABLET, EXTENDED RELEASE;ORAL	EQ 400MG TARTRATE	METOPROLOL FUMARATE	1989-12-27	Discontinued	No
072687	ANDA	NOVARTIS	001	FOAMICON	TABLET, CHEWABLE;ORAL	80MG;20MG	ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE	1989-06-28	Discontinued	No
019667	NDA	NOVARTIS	001	SANDOSTATIN	INJECTABLE;INJECTION	EQ 0.05MG BASE/ML	OCTREOTIDE ACETATE	1988-10-21	Prescription	Yes
			002	SANDOSTATIN	INJECTABLE;INJECTION	EQ 0.1MG BASE/ML	OCTREOTIDE ACETATE	1988-10-21	Prescription	Yes
			003	SANDOSTATIN	INJECTABLE;INJECTION	EQ 0.5MG BASE/ML	OCTREOTIDE ACETATE	1988-10-21	Prescription	Yes
			004	SANDOSTATIN	INJECTABLE;INJECTION	EQ 0.2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OCTREOTIDE ACETATE	1988-10-21	Discontinued	No
			005	SANDOSTATIN	INJECTABLE;INJECTION	EQ 1MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OCTREOTIDE ACETATE	1988-10-21	Discontinued	No
050616	NDA	NOVARTIS	001	TOBRADEX	OINTMENT;OPHTHALMIC	0.1%;0.3%	DEXAMETHASONE; TOBRAMYCIN	1988-09-28	Prescription	Yes
018988	NDA	NOVARTIS	001	VASOCIDIN	SOLUTION/DROPS;OPHTHALMIC	EQ 0.23% PHOSPHATE;10% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM	1988-08-26	Discontinued	No
019201	NDA	NOVARTIS	001	VOLTAREN	TABLET, DELAYED RELEASE;ORAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	DICLOFENAC SODIUM	1988-07-28	Discontinued	No
			002	VOLTAREN	TABLET, DELAYED RELEASE;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	DICLOFENAC SODIUM	1988-07-28	Discontinued	No
			003	VOLTAREN	TABLET, DELAYED RELEASE;ORAL	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	DICLOFENAC SODIUM	1988-07-28	Discontinued	No
018927	NDA	NOVARTIS	001	TEGRETOL	SUSPENSION;ORAL	100MG/5ML	CARBAMAZEPINE	1987-12-18	Prescription	Yes
019500	NDA	NOVARTIS	001	LAMPRENE	CAPSULE;ORAL	100MG	CLOFAZIMINE	1986-12-15	Discontinued	No
019500	NDA	NOVARTIS	002	LAMPRENE	CAPSULE;ORAL	50MG	CLOFAZIMINE	1986-12-15	Discontinued	No
018470	NDA	NOVARTIS	001	CIBACALCIN	INJECTABLE;INJECTION	0.5MG/VIAL	CALCITONIN HUMAN	1986-10-31	Discontinued	No
019081	NDA	NOVARTIS	002	ESTRADERM	SYSTEM;TRANSDERMAL	0.05MG/24HR	ESTRADIOL	1986-09-10	Discontinued	No
019081	NDA	NOVARTIS	003	ESTRADERM	SYSTEM;TRANSDERMAL	0.1MG/24HR	ESTRADIOL	1986-09-10	Discontinued	No
070185	ANDA	NOVARTIS	001	FLUOR-OP	SUSPENSION/DROPS;OPHTHALMIC	0.1%	FLUOROMETHOLONE	1986-02-27	Discontinued	No
018675	NDA	NOVARTIS	001	TAVIST	SYRUP;ORAL	EQ 0.5MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CLEMASTINE FUMARATE	1985-06-28	Discontinued	No
062566	ANDA	NOVARTIS	001	DEXACIDIN	OINTMENT;OPHTHALMIC	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	1985-02-22	Discontinued	No
062544	ANDA	NOVARTIS	001	DEXACIDIN	SUSPENSION/DROPS;OPHTHALMIC	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	1984-10-29	Discontinued	No
088791	ANDA	NOVARTIS	001	VASOCIDIN	OINTMENT;OPHTHALMIC	0.5%;10%	PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM	1984-10-05	Discontinued	No
062501	ANDA	NOVARTIS	001	GENTACIDIN	OINTMENT;OPHTHALMIC	EQ 0.3% BASE	GENTAMICIN SULFATE	1984-07-26	Discontinued	No
062480	ANDA	NOVARTIS	001	GENTACIDIN	SOLUTION/DROPS;OPHTHALMIC	EQ 0.3% BASE	GENTAMICIN SULFATE	1984-03-30	Discontinued	No
018704	NDA	NOVARTIS	001	LOPRESSOR	INJECTABLE;INJECTION	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	METOPROLOL TARTRATE	1984-03-30	Discontinued	No
050573	NDA	NOVARTIS	001	SANDIMMUNE	INJECTABLE;INJECTION	50MG/ML	CYCLOSPORINE	1983-11-14	Prescription	Yes
050574	NDA	NOVARTIS	001	SANDIMMUNE	SOLUTION;ORAL	100MG/ML	CYCLOSPORINE	1983-11-14	Prescription	Yes
018706	NDA	NOVARTIS	001	HYDERGINE LC	CAPSULE;ORAL	1MG	ERGOLOID MESYLATES	1983-01-18	Discontinued	No
018285	NDA	NOVARTIS	001	VISKEN	TABLET;ORAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PINDOLOL	1982-09-03	Discontinued	No
018285	NDA	NOVARTIS	002	VISKEN	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PINDOLOL	1982-09-03	Discontinued	No
018029	NDA	NOVARTIS	001	RITALIN-SR	TABLET, EXTENDED RELEASE;ORAL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	METHYLPHENIDATE HYDROCHLORIDE	1982-03-30	Discontinued	No
018281	NDA	NOVARTIS	001	TEGRETOL	TABLET, CHEWABLE;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CARBAMAZEPINE	1981-12-14	Discontinued	No
050555	NDA	NOVARTIS	001	TOBREX	OINTMENT;OPHTHALMIC	0.3%	TOBRAMYCIN	1981-11-25	Prescription	Yes
020144	NDA	NOVARTIS	001	TRANSDERM-NITRO	FILM, EXTENDED RELEASE;TRANSDERMAL	0.1MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	NITROGLYCERIN	1981-10-19	Discontinued	No
			002	TRANSDERM-NITRO	FILM, EXTENDED RELEASE;TRANSDERMAL	0.2MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	NITROGLYCERIN	1981-10-19	Discontinued	No
			003	TRANSDERM-NITRO	FILM, EXTENDED RELEASE;TRANSDERMAL	0.4MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	NITROGLYCERIN	1981-10-19	Discontinued	No
			004	TRANSDERM-NITRO	FILM, EXTENDED RELEASE;TRANSDERMAL	0.6MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	NITROGLYCERIN	1981-10-19	Discontinued	No
			005	TRANSDERM-NITRO	FILM, EXTENDED RELEASE;TRANSDERMAL	0.8MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	NITROGLYCERIN	1981-10-19	Discontinued	No
018418	NDA	NOVARTIS	001	HYDERGINE	SOLUTION;ORAL	1MG/ML	ERGOLOID MESYLATES	1981-01-30	Discontinued	No
050541	NDA	NOVARTIS	001	TOBREX	SOLUTION/DROPS;OPHTHALMIC	0.3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TOBRAMYCIN	1980-12-12	Discontinued	No
017543	NDA	NOVARTIS	001	LUDIOMIL	TABLET;ORAL	25MG	MAPROTILINE HYDROCHLORIDE	1980-12-01	Discontinued	No
			002	LUDIOMIL	TABLET;ORAL	50MG	MAPROTILINE HYDROCHLORIDE	1980-12-01	Discontinued	No
			003	LUDIOMIL	TABLET;ORAL	75MG	MAPROTILINE HYDROCHLORIDE	1980-12-01	Discontinued	No
018202	NDA	NOVARTIS	001	CYTADREN	TABLET;ORAL	250MG	AMINOGLUTETHIMIDE	1980-10-29	Discontinued	No
018245	NDA	NOVARTIS	001	SYNTOCINON	INJECTABLE;INJECTION	10USP UNITS/ML	OXYTOCIN	1980-04-17	Discontinued	No
017923	NDA	NOVARTIS	001	MELLARIL-S	SUSPENSION;ORAL	EQ 25MG HYDROCHLORIDE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	THIORIDAZINE	1978-10-18	Discontinued	No
017923	NDA	NOVARTIS	002	MELLARIL-S	SUSPENSION;ORAL	EQ 100MG HYDROCHLORIDE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	THIORIDAZINE	1978-10-18	Discontinued	No
017993	NDA	NOVARTIS	001	HYDERGINE	TABLET;ORAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ERGOLOID MESYLATES	1977-12-30	Discontinued	No
017993	NDA	NOVARTIS	003	HYDERGINE	TABLET;ORAL	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ERGOLOID MESYLATES	1977-12-30	Discontinued	No
017851	NDA	NOVARTIS	001	LIORESAL	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	BACLOFEN	1977-11-22	Discontinued	No
017851	NDA	NOVARTIS	003	LIORESAL	TABLET;ORAL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	BACLOFEN	1977-11-22	Discontinued	No
017661	NDA	NOVARTIS	001	TAVIST	TABLET;ORAL	2.68MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CLEMASTINE FUMARATE	1977-02-25	Discontinued	No
			002	TAVIST-1	TABLET;ORAL	1.34MG	CLEMASTINE FUMARATE	1977-02-25	Discontinued	No
			003	TAVIST-1	TABLET;ORAL	1.34MG	CLEMASTINE FUMARATE	1977-02-25	Discontinued	No
017869	NDA	NOVARTIS	001	FUNDUSCEIN-25	INJECTABLE;INJECTION	25% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FLUORESCEIN SODIUM	1976-11-10	Discontinued	No
084735	ANDA	NOVARTIS	001	APRESAZIDE	CAPSULE;ORAL	25MG;25MG	HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	1976-05-26	Discontinued	No
084810	ANDA	NOVARTIS	001	APRESAZIDE	CAPSULE;ORAL	50MG;50MG	HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	1976-05-26	Discontinued	No
084811	ANDA	NOVARTIS	001	APRESAZIDE	CAPSULE;ORAL	100MG;50MG	HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	1976-05-26	Discontinued	No
017476	NDA	NOVARTIS	002	SLOW-K	TABLET, EXTENDED RELEASE;ORAL	8MEQ	POTASSIUM CHLORIDE	1975-04-25	Discontinued	No
080751	ANDA	NOVARTIS	002	INFLAMASE FORTE	SOLUTION/DROPS;OPHTHALMIC	EQ 0.9% PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	1973-12-19	Discontinued	No
080751	ANDA	NOVARTIS	001	INFLAMASE MILD	SOLUTION/DROPS;OPHTHALMIC	EQ 0.11% PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	1973-12-19	Discontinued	No
016211	NDA	NOVARTIS	001	MIOCHOL	FOR SOLUTION;OPHTHALMIC	20MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ACETYLCHOLINE CHLORIDE	1973-10-09	Discontinued	No
083149	ANDA	NOVARTIS	001	PBZ	TABLET;ORAL	25MG	TRIPELENNAMINE HYDROCHLORIDE	1973-09-06	Discontinued	No
017247	NDA	NOVARTIS	001	SANOREX	TABLET;ORAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	MAZINDOL	1973-06-14	Discontinued	No
017247	NDA	NOVARTIS	002	SANOREX	TABLET;ORAL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	MAZINDOL	1973-06-14	Discontinued	No
016997	NDA	NOVARTIS	001	SERENTIL	CONCENTRATE;ORAL	EQ 25MG BASE/ML	MESORIDAZINE BESYLATE	1972-01-31	Discontinued	No
080235	ANDA	NOVARTIS	002	VASOCON	SOLUTION/DROPS;OPHTHALMIC	0.1%	NAPHAZOLINE HYDROCHLORIDE	1971-06-07	Discontinued	No
016774	NDA	NOVARTIS	001	SERENTIL	TABLET;ORAL	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	MESORIDAZINE BESYLATE	1970-02-27	Discontinued	No
			002	SERENTIL	TABLET;ORAL	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	MESORIDAZINE BESYLATE	1970-02-27	Discontinued	No
			003	SERENTIL	TABLET;ORAL	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	MESORIDAZINE BESYLATE	1970-02-27	Discontinued	No
			004	SERENTIL	TABLET;ORAL	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	MESORIDAZINE BESYLATE	1970-02-27	Discontinued	No
016775	NDA	NOVARTIS	001	SERENTIL	INJECTABLE;INJECTION	EQ 25MG BASE/ML	MESORIDAZINE BESYLATE	1970-02-27	Discontinued	No
009436	NDA	NOVARTIS	001	ACYLANID	TABLET;ORAL	0.1MG	ACETYLDIGITOXIN		Discontinued	No
008492	NDA	NOVARTIS	002	ANTRENYL	TABLET;ORAL	5MG	OXYPHENONIUM BROMIDE		Discontinued	No
012026	NDA	NOVARTIS	002	APRESOLINE-ESIDRIX	TABLET;ORAL	25MG;15MG	HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE		Discontinued	No
085148	ANDA	NOVARTIS	001	ASBRON	TABLET;ORAL	EQ 150MG BASE	THEOPHYLLINE SODIUM GLYCINATE		Discontinued	No
018762	NDA	NOVARTIS	001	BRETHAIRE	AEROSOL, METERED;INHALATION	0.2MG/INH	TERBUTALINE SULFATE		Discontinued	No
009282	NDA	NOVARTIS	002	CEDILANID-D	INJECTABLE;INJECTION	0.2MG/ML	DESLANOSIDE		Discontinued	No
016755	NDA	NOVARTIS	001	DIAPID	SOLUTION;NASAL	0.185MG/ML	LYPRESSIN		Discontinued	No
018885	NDA	NOVARTIS	001	EMBOLEX	INJECTABLE;INJECTION	0.5MG/0.5ML;2,500 UNITS/0.5ML;5.33MG/0.5ML	DIHYDROERGOTAMINE MESYLATE; HEPARIN SODIUM; LIDOCAINE HYDROCHLORIDE		Discontinued	No
018885	NDA	NOVARTIS	002	EMBOLEX	INJECTABLE;INJECTION	0.5MG/0.7ML;5,000 UNITS/0.7ML;7.46MG/0.7ML	DIHYDROERGOTAMINE MESYLATE; HEPARIN SODIUM; LIDOCAINE HYDROCHLORIDE		Discontinued	No
013553	NDA	NOVARTIS	001	ESIMIL	TABLET;ORAL	10MG;25MG	GUANETHIDINE MONOSULFATE; HYDROCHLOROTHIAZIDE		Discontinued	No
006203	NDA	NOVARTIS	001	HEAVY SOLUTION NUPERCAINE	INJECTABLE;INJECTION	2.5MG/ML	DIBUCAINE HYDROCHLORIDE		Discontinued	No
086765	ANDA	NOVARTIS	001	IMIPRAMINE HYDROCHLORIDE	CONCENTRATE;ORAL	25MG/ML	IMIPRAMINE HYDROCHLORIDE		Discontinued	No
080935	ANDA	NOVARTIS	001	INH	TABLET;ORAL	300MG	ISONIAZID		Discontinued	No
016379	NDA	NOVARTIS	001	LOCORTEN	CREAM;TOPICAL	0.03%	FLUMETHASONE PIVALATE		Discontinued	No
019451	NDA	NOVARTIS	001	LOPRESSIDONE	CAPSULE;ORAL	25MG;100MG	CHLORTHALIDONE; METOPROLOL TARTRATE		Discontinued	No
019451	NDA	NOVARTIS	002	LOPRESSIDONE	CAPSULE;ORAL	25MG;200MG	CHLORTHALIDONE; METOPROLOL TARTRATE		Discontinued	No
003240	NDA	NOVARTIS	001	METANDREN	TABLET;BUCCAL, SUBLINGUAL	10MG	METHYLTESTOSTERONE		Discontinued	No
			003	METANDREN	TABLET;BUCCAL, SUBLINGUAL	25MG	METHYLTESTOSTERONE		Discontinued	No
			004	METANDREN	TABLET;BUCCAL, SUBLINGUAL	5MG	METHYLTESTOSTERONE		Discontinued	No
			005	METANDREN	TABLET;BUCCAL, SUBLINGUAL	10MG	METHYLTESTOSTERONE		Discontinued	No
008822	NDA	NOVARTIS	001	PERCORTEN	INJECTABLE;INJECTION	25MG/ML	DESOXYCORTICOSTERONE PIVALATE		Discontinued	No
009215	NDA	NOVARTIS	001	RAUTENSIN	TABLET;ORAL	2MG	ALSEROXYLON		Discontinued	No
080025	ANDA	NOVARTIS	001	SULF-10	SOLUTION/DROPS;OPHTHALMIC	10%	SULFACETAMIDE SODIUM		Discontinued	No
019381	NDA	NOVARTIS	001	TEN-K	TABLET, EXTENDED RELEASE;ORAL	10MEQ	POTASSIUM CHLORIDE		Discontinued	No
018166	NDA	NOVARTIS	001	TRASICOR	CAPSULE;ORAL	20MG	OXPRENOLOL HYDROCHLORIDE		Discontinued	No
			002	TRASICOR	CAPSULE;ORAL	40MG	OXPRENOLOL HYDROCHLORIDE		Discontinued	No
			003	TRASICOR	CAPSULE;ORAL	80MG	OXPRENOLOL HYDROCHLORIDE		Discontinued	No
			004	TRASICOR	CAPSULE;ORAL	160MG	OXPRENOLOL HYDROCHLORIDE		Discontinued	No
013420	NDA	NOVARTIS	001	TREST	TABLET;ORAL	1MG	METHIXENE HYDROCHLORIDE		Discontinued	No
018115	NDA	NOVARTIS	001	TRIAMINIC-12	TABLET, EXTENDED RELEASE;ORAL	12MG;75MG	CHLORPHENIRAMINE MALEATE; PHENYLPROPANOLAMINE HYDROCHLORIDE		Discontinued	No
074857	ANDA	NOVARTIS	001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	CAPSULE;ORAL	25MG;37.5MG	HYDROCHLOROTHIAZIDE; TRIAMTERENE		Discontinued	No
018872	NDA	NOVARTIS	001	VISKAZIDE	TABLET;ORAL	25MG;5MG	HYDROCHLOROTHIAZIDE; PINDOLOL		Discontinued	No
018872	NDA	NOVARTIS	002	VISKAZIDE	TABLET;ORAL	25MG;10MG	HYDROCHLOROTHIAZIDE; PINDOLOL		Discontinued	No
016608	NDA	NOVARTIS	001	TEGRETOL	TABLET;ORAL	200MG	CARBAMAZEPINE	1968-03-11	Prescription	Yes
013247	NDA	NOVARTIS	001	TORECAN	SUPPOSITORY;RECTAL	10MG	THIETHYLPERAZINE MALEATE	1963-04-11	Discontinued	No
011808	NDA	NOVARTIS	003	MELLARIL	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	THIORIDAZINE HYDROCHLORIDE	1962-03-15	Discontinued	No
			006	MELLARIL	TABLET;ORAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	THIORIDAZINE HYDROCHLORIDE	1962-03-15	Discontinued	No
			009	MELLARIL	TABLET;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	THIORIDAZINE HYDROCHLORIDE	1962-03-15	Discontinued	No
			011	MELLARIL	TABLET;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	THIORIDAZINE HYDROCHLORIDE	1962-03-15	Discontinued	No
			012	MELLARIL	CONCENTRATE;ORAL	30MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	THIORIDAZINE HYDROCHLORIDE	1962-03-15	Discontinued	No
			015	MELLARIL	TABLET;ORAL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	THIORIDAZINE HYDROCHLORIDE	1962-03-15	Discontinued	No
			016	MELLARIL	TABLET;ORAL	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	THIORIDAZINE HYDROCHLORIDE	1962-03-15	Discontinued	No
			017	MELLARIL	TABLET;ORAL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	THIORIDAZINE HYDROCHLORIDE	1962-03-15	Discontinued	No
			018	MELLARIL	CONCENTRATE;ORAL	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	THIORIDAZINE HYDROCHLORIDE	1962-03-15	Discontinued	No
012516	NDA	NOVARTIS	001	SANSERT	TABLET;ORAL	2MG	METHYSERGIDE MALEATE	1962-02-12	Discontinued	No
012753	NDA	NOVARTIS	001	TORECAN	TABLET;ORAL	10MG	THIETHYLPERAZINE MALEATE	1961-07-18	Discontinued	No
012754	NDA	NOVARTIS	002	TORECAN	INJECTABLE;INJECTION	5MG/ML	THIETHYLPERAZINE MALATE	1961-07-18	Discontinued	No
012542	NDA	NOVARTIS	004	TANDEARIL	TABLET;ORAL	100MG	OXYPHENBUTAZONE	1960-12-21	Discontinued	No
012329	NDA	NOVARTIS	001	ISMELIN	TABLET;ORAL	EQ 10MG SULFATE	GUANETHIDINE MONOSULFATE	1960-07-05	Discontinued	No
012329	NDA	NOVARTIS	002	ISMELIN	TABLET;ORAL	EQ 25MG SULFATE	GUANETHIDINE MONOSULFATE	1960-07-05	Discontinued	No
012193	NDA	NOVARTIS	005	SER-AP-ES	TABLET;ORAL	25MG;15MG;0.1MG	HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE	1960-02-11	Discontinued	No
011838	NDA	NOVARTIS	002	TOFRANIL	INJECTABLE;INJECTION	12.5MG/ML	IMIPRAMINE HYDROCHLORIDE	1959-10-02	Discontinued	No
011556	NDA	NOVARTIS	003	ANTURANE	TABLET;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SULFINPYRAZONE	1959-05-13	Discontinued	No
011556	NDA	NOVARTIS	004	ANTURANE	CAPSULE;ORAL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SULFINPYRAZONE	1959-05-13	Discontinued	No
011878	NDA	NOVARTIS	003	SERPASIL-ESIDRIX #1	TABLET;ORAL	25MG;0.1MG	HYDROCHLOROTHIAZIDE; RESERPINE	1959-05-05	Discontinued	No
011878	NDA	NOVARTIS	005	SERPASIL-ESIDRIX #2	TABLET;ORAL	50MG;0.1MG	HYDROCHLOROTHIAZIDE; RESERPINE	1959-05-05	Discontinued	No
011793	NDA	NOVARTIS	005	ESIDRIX	TABLET;ORAL	25MG	HYDROCHLOROTHIAZIDE	1959-02-12	Discontinued	No
			008	ESIDRIX	TABLET;ORAL	50MG	HYDROCHLOROTHIAZIDE	1959-02-12	Discontinued	No
			009	ESIDRIX	TABLET;ORAL	100MG	HYDROCHLOROTHIAZIDE	1959-02-12	Discontinued	No
010533	NDA	NOVARTIS	001	PBZ-SR	TABLET, EXTENDED RELEASE;ORAL	100MG	TRIPELENNAMINE HYDROCHLORIDE	1956-07-05	Discontinued	No
010533	NDA	NOVARTIS	002	PBZ-SR	TABLET, EXTENDED RELEASE;ORAL	50MG	TRIPELENNAMINE HYDROCHLORIDE	1956-07-05	Discontinued	No
009115	NDA	NOVARTIS	001	SERPASIL	TABLET;ORAL	0.1MG	RESERPINE	1955-08-12	Discontinued	No
			003	SERPASIL	TABLET;ORAL	0.25MG	RESERPINE	1955-08-12	Discontinued	No
			004	SERPASIL	TABLET;ORAL	1MG	RESERPINE	1955-08-12	Discontinued	No
			005	SERPASIL	ELIXIR;ORAL	0.2MG/4ML	RESERPINE	1955-08-12	Discontinued	No
009434	NDA	NOVARTIS	002	SERPASIL	INJECTABLE;INJECTION	2.5MG/ML	RESERPINE	1954-08-13	Discontinued	No
009296	NDA	NOVARTIS	002	SERPASIL-APRESOLINE	TABLET;ORAL	50MG;0.2MG	HYDRALAZINE HYDROCHLORIDE; RESERPINE	1954-04-01	Discontinued	No
009296	NDA	NOVARTIS	004	SERPASIL-APRESOLINE	TABLET;ORAL	25MG;0.1MG	HYDRALAZINE HYDROCHLORIDE; RESERPINE	1954-04-01	Discontinued	No
009087	NDA	NOVARTIS	001	HYDERGINE	TABLET;SUBLINGUAL	1MG	ERGOLOID MESYLATES	1953-11-05	Discontinued	No
009087	NDA	NOVARTIS	002	HYDERGINE	TABLET;SUBLINGUAL	0.5MG	ERGOLOID MESYLATES	1953-11-05	Discontinued	No
009000	NDA	NOVARTIS	002	CAFERGOT	SUPPOSITORY;RECTAL	100MG;2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAFFEINE; ERGOTAMINE TARTRATE	1953-04-24	Discontinued	No
008303	NDA	NOVARTIS	001	APRESOLINE	TABLET;ORAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	HYDRALAZINE HYDROCHLORIDE	1953-01-15	Discontinued	No
			002	APRESOLINE	TABLET;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	HYDRALAZINE HYDROCHLORIDE	1953-01-15	Discontinued	No
			003	APRESOLINE	INJECTABLE;INJECTION	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	HYDRALAZINE HYDROCHLORIDE	1953-01-15	Discontinued	No
			004	APRESOLINE	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	HYDRALAZINE HYDROCHLORIDE	1953-01-15	Discontinued	No
			005	APRESOLINE	TABLET;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	HYDRALAZINE HYDROCHLORIDE	1953-01-15	Discontinued	No
008278	NDA	NOVARTIS	003	REGITINE	INJECTABLE;INJECTION	5MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PHENTOLAMINE MESYLATE	1952-01-30	Discontinued	No
006620	NDA	NOVARTIS	001	CAFERGOT	TABLET;ORAL	100MG;1MG	CAFFEINE; ERGOTAMINE TARTRATE	1948-11-26	Discontinued	No
006403	NDA	NOVARTIS	005	PRISCOLINE	INJECTABLE;INJECTION	25MG/ML	TOLAZOLINE HYDROCHLORIDE	1948-03-17	Discontinued	No
005914	NDA	NOVARTIS	002	PBZ	TABLET;ORAL	50MG	TRIPELENNAMINE HYDROCHLORIDE	1948-02-19	Discontinued	No
005914	NDA	NOVARTIS	004	PBZ	ELIXIR;ORAL	EQ 25MG HYDROCHLORIDE/5ML	TRIPELENNAMINE CITRATE	1948-02-19	Discontinued	No
006008	NDA	NOVARTIS	001	MESANTOIN	TABLET;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	MEPHENYTOIN	1946-10-23	Discontinued	No
005151	NDA	NOVARTIS	001	PERCORTEN	PELLET;IMPLANTATION	125MG	DESOXYCORTICOSTERONE ACETATE	1942-12-09	Discontinued	No