FDA Approved Products

Application #	Type	Sponsor	Product #	Drug Name	Form	Strength	Active Ingredient	Approval Date	Marketing Status	Reference Standard
206497	ANDA	MYLAN TECH VIATRIS	001	METHYLPHENIDATE	FILM, EXTENDED RELEASE;TRANSDERMAL	10MG/9HR (1.1MG/HR)	METHYLPHENIDATE	2022-03-14	Prescription	No
			002	METHYLPHENIDATE	FILM, EXTENDED RELEASE;TRANSDERMAL	15MG/9HR (1.6MG/HR)	METHYLPHENIDATE	2022-03-14	Prescription	No
			003	METHYLPHENIDATE	FILM, EXTENDED RELEASE;TRANSDERMAL	20MG/9HR (2.2MG/HR)	METHYLPHENIDATE	2022-03-14	Prescription	No
			004	METHYLPHENIDATE	FILM, EXTENDED RELEASE;TRANSDERMAL	30MG/9HR (3.3MG/HR)	METHYLPHENIDATE	2022-03-14	Prescription	No
210162	ANDA	MYLAN TECH VIATRIS	001	BUPRENORPHINE	FILM, EXTENDED RELEASE;TRANSDERMAL	5MCG/HR	BUPRENORPHINE	2021-05-03	Discontinued	No
			002	BUPRENORPHINE	FILM, EXTENDED RELEASE;TRANSDERMAL	7.5MCG/HR	BUPRENORPHINE	2021-05-03	Discontinued	No
			003	BUPRENORPHINE	FILM, EXTENDED RELEASE;TRANSDERMAL	10MCG/HR	BUPRENORPHINE	2021-05-03	Discontinued	No
			004	BUPRENORPHINE	FILM, EXTENDED RELEASE;TRANSDERMAL	15MCG/HR	BUPRENORPHINE	2021-05-03	Discontinued	No
			005	BUPRENORPHINE	FILM, EXTENDED RELEASE;TRANSDERMAL	20MCG/HR	BUPRENORPHINE	2021-05-03	Discontinued	No
201688	NDA	VIATRIS	001	TOBI PODHALER	POWDER;INHALATION	28MG	TOBRAMYCIN	2013-03-22	Prescription	Yes
203109	NDA	VIATRIS	001	REVATIO	FOR SUSPENSION;ORAL	EQ 10MG BASE/ML	SILDENAFIL CITRATE	2012-08-30	Prescription	Yes
022473	NDA	VIATRIS	001	REVATIO	SOLUTION;INTRAVENOUS	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SILDENAFIL CITRATE	2009-11-18	Prescription	Yes
021997	NDA	VIATRIS	001	EDLUAR	TABLET;SUBLINGUAL	5MG	ZOLPIDEM TARTRATE	2009-03-13	Prescription	No
021997	NDA	VIATRIS	002	EDLUAR	TABLET;SUBLINGUAL	10MG	ZOLPIDEM TARTRATE	2009-03-13	Prescription	Yes
022203	NDA	VIATRIS	001	ASTEPRO	SPRAY, METERED;NASAL	0.137MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AZELASTINE HYDROCHLORIDE	2008-10-15	Discontinued	No
022203	NDA	VIATRIS	002	ASTEPRO	SPRAY, METERED;NASAL	0.2055MG/SPRAY	AZELASTINE HYDROCHLORIDE	2008-10-15	Discontinued	No
022007	NDA	VIATRIS SPECIALTY	001	PERFOROMIST	SOLUTION;INHALATION	0.02MG/2ML	FORMOTEROL FUMARATE	2007-05-11	Prescription	Yes
021813	NDA	VIATRIS	001	ELESTRIN	GEL, METERED;TRANSDERMAL	0.06% (0.87GM/ACTIVATION)	ESTRADIOL	2006-12-15	Prescription	Yes
021845	NDA	VIATRIS	001	REVATIO	TABLET;ORAL	EQ 20MG BASE	SILDENAFIL CITRATE	2005-06-03	Prescription	Yes
021269	NDA	VIATRIS	001	CARDURA XL	TABLET, EXTENDED RELEASE;ORAL	EQ 4MG BASE	DOXAZOSIN MESYLATE	2005-02-22	Prescription	No
021269	NDA	VIATRIS	002	CARDURA XL	TABLET, EXTENDED RELEASE;ORAL	EQ 8MG BASE	DOXAZOSIN MESYLATE	2005-02-22	Prescription	Yes
020919	NDA	VIATRIS	001	GEODON	POWDER;INTRAMUSCULAR	EQ 20MG BASE/VIAL	ZIPRASIDONE MESYLATE	2002-06-21	Prescription	Yes
020825	NDA	VIATRIS	001	GEODON	CAPSULE;ORAL	EQ 20MG BASE	ZIPRASIDONE HYDROCHLORIDE	2001-02-05	Prescription	Yes
			002	GEODON	CAPSULE;ORAL	EQ 40MG BASE	ZIPRASIDONE HYDROCHLORIDE	2001-02-05	Prescription	No
			003	GEODON	CAPSULE;ORAL	EQ 60MG BASE	ZIPRASIDONE HYDROCHLORIDE	2001-02-05	Prescription	No
			004	GEODON	CAPSULE;ORAL	EQ 80MG BASE	ZIPRASIDONE HYDROCHLORIDE	2001-02-05	Prescription	No
021134	NDA	VIATRIS	001	NITROSTAT	TABLET;SUBLINGUAL	0.3MG	NITROGLYCERIN	2000-05-01	Prescription	No
			002	NITROSTAT	TABLET;SUBLINGUAL	0.4MG	NITROGLYCERIN	2000-05-01	Prescription	No
			003	NITROSTAT	TABLET;SUBLINGUAL	0.6MG	NITROGLYCERIN	2000-05-01	Prescription	Yes
021129	NDA	VIATRIS	001	NEURONTIN	SOLUTION;ORAL	250MG/5ML	GABAPENTIN	2000-03-02	Prescription	Yes
020990	NDA	VIATRIS	001	ZOLOFT	CONCENTRATE;ORAL	EQ 20MG BASE/ML	SERTRALINE HYDROCHLORIDE	1999-12-07	Prescription	Yes
020882	NDA	VIATRIS	001	NEURONTIN	TABLET;ORAL	600MG	GABAPENTIN	1998-10-09	Prescription	No
020882	NDA	VIATRIS	002	NEURONTIN	TABLET;ORAL	800MG	GABAPENTIN	1998-10-09	Prescription	Yes
020895	NDA	VIATRIS	001	VIAGRA	TABLET;ORAL	EQ 25MG BASE	SILDENAFIL CITRATE	1998-03-27	Prescription	No
			002	VIAGRA	TABLET;ORAL	EQ 50MG BASE	SILDENAFIL CITRATE	1998-03-27	Prescription	No
			003	VIAGRA	TABLET;ORAL	EQ 100MG BASE	SILDENAFIL CITRATE	1998-03-27	Prescription	Yes
050753	NDA	VIATRIS	001	TOBI	SOLUTION;INHALATION	300MG/5ML	TOBRAMYCIN	1997-12-22	Prescription	Yes
020700	NDA	VIATRIS	001	MUSE	SUPPOSITORY;URETHRAL	0.125MG	ALPROSTADIL	1996-11-19	Discontinued	No
			002	MUSE	SUPPOSITORY;URETHRAL	0.25MG	ALPROSTADIL	1996-11-19	Discontinued	No
			003	MUSE	SUPPOSITORY;URETHRAL	0.5MG	ALPROSTADIL	1996-11-19	Discontinued	No
			004	MUSE	SUPPOSITORY;URETHRAL	1MG	ALPROSTADIL	1996-11-19	Discontinued	No
020479	NDA	VIATRIS SPECIALTY	001	GASTROCROM	CONCENTRATE;ORAL	100MG/5ML	CROMOLYN SODIUM	1996-02-29	Prescription	Yes
020235	NDA	VIATRIS	001	NEURONTIN	CAPSULE;ORAL	100MG	GABAPENTIN	1993-12-30	Prescription	No
			002	NEURONTIN	CAPSULE;ORAL	300MG	GABAPENTIN	1993-12-30	Prescription	No
			003	NEURONTIN	CAPSULE;ORAL	400MG	GABAPENTIN	1993-12-30	Prescription	Yes
019787	NDA	VIATRIS	001	NORVASC	TABLET;ORAL	EQ 2.5MG BASE	AMLODIPINE BESYLATE	1992-07-31	Prescription	No
			002	NORVASC	TABLET;ORAL	EQ 5MG BASE	AMLODIPINE BESYLATE	1992-07-31	Prescription	No
			003	NORVASC	TABLET;ORAL	EQ 10MG BASE	AMLODIPINE BESYLATE	1992-07-31	Prescription	Yes
019839	NDA	VIATRIS	001	ZOLOFT	TABLET;ORAL	EQ 50MG BASE	SERTRALINE HYDROCHLORIDE	1991-12-30	Prescription	No
			002	ZOLOFT	TABLET;ORAL	EQ 100MG BASE	SERTRALINE HYDROCHLORIDE	1991-12-30	Prescription	Yes
			003	ZOLOFT	TABLET;ORAL	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SERTRALINE HYDROCHLORIDE	1991-12-30	Discontinued	No
			004	ZOLOFT	TABLET;ORAL	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SERTRALINE HYDROCHLORIDE	1991-12-30	Discontinued	No
			005	ZOLOFT	TABLET;ORAL	EQ 25MG BASE	SERTRALINE HYDROCHLORIDE	1991-12-30	Prescription	No
019668	NDA	VIATRIS	001	CARDURA	TABLET;ORAL	EQ 1MG BASE	DOXAZOSIN MESYLATE	1990-11-02	Prescription	Yes
			002	CARDURA	TABLET;ORAL	EQ 2MG BASE	DOXAZOSIN MESYLATE	1990-11-02	Prescription	No
			003	CARDURA	TABLET;ORAL	EQ 4MG BASE	DOXAZOSIN MESYLATE	1990-11-02	Prescription	No
			004	CARDURA	TABLET;ORAL	EQ 8MG BASE	DOXAZOSIN MESYLATE	1990-11-02	Prescription	No
019715	NDA	MYLAN SPCLT VIATRIS	001	DIPENTUM	CAPSULE;ORAL	250MG	OLSALAZINE SODIUM	1990-07-31	Prescription	Yes
019430	NDA	VIATRIS	004	EPI E Z PEN JR	INJECTABLE;INTRAMUSCULAR	0.15MG/DELIVERY	EPINEPHRINE	1987-12-22	Discontinued	No
			001	EPIPEN	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	0.3MG/DELIVERY	EPINEPHRINE	1987-12-22	Prescription	Yes
			003	EPIPEN E Z PEN	INJECTABLE;INTRAMUSCULAR	0.3MG/DELIVERY	EPINEPHRINE	1987-12-22	Discontinued	No
			002	EPIPEN JR.	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	0.15MG/DELIVERY	EPINEPHRINE	1987-12-22	Prescription	Yes
017351	NDA	VIATRIS	001	CORTIFOAM	AEROSOL, METERED;RECTAL	10%	HYDROCORTISONE ACETATE	1982-02-12	Prescription	Yes
084349	ANDA	VIATRIS	001	DILANTIN	CAPSULE;ORAL	30MG EXTENDED	PHENYTOIN SODIUM	1976-08-27	Prescription	Yes
084349	ANDA	VIATRIS	002	DILANTIN	CAPSULE;ORAL	100MG EXTENDED	PHENYTOIN SODIUM	1976-08-27	Prescription	Yes
215682	ANDA	MYLAN PHARMACEUTICALS INC A VIATRIS CO	002	PALIPERIDONE PALMITATE	INJECTION;SUSPENSION	410MG/1.315ML	PALIPERIDONE PALMITATE		None (Tentative Approval)	No
			003	PALIPERIDONE PALMITATE	INJECTION;SUSPENSION	546MG/1.75ML	PALIPERIDONE PALMITATE		None (Tentative Approval)	No
			004	PALIPERIDONE PALMITATE	INJECTION;SUSPENSION	819MG/2.625ML	PALIPERIDONE PALMITATE		None (Tentative Approval)	No
			005	PALIPERIDONE PALMITATE	INJECTION;SUSPENSION	1092MG/3.5ML	PALIPERIDONE PALMITATE		None (Tentative Approval)	No
			006	PALIPERIDONE PALMITATE	INJECTION;SUSPENSION	1560MG/5.0ML	PALIPERIDONE PALMITATE		None (Tentative Approval)	No
076981	ANDA	ALPHAPHARM	001	ESCITALOPRAM	TABLET; ORAL	5MG	ESCITALOPRAM OXALATE		None (Tentative Approval)	No
			002	ESCITALOPRAM	TABLET; ORAL	10MG	ESCITALOPRAM OXALATE		None (Tentative Approval)	No
			003	ESCITALOPRAM	TABLET; ORAL	20MG	ESCITALOPRAM OXALATE		None (Tentative Approval)	No
076799	ANDA	ALPHAPHARM	001	PIOGLITAZONE	TABLET; ORAL	15MG	PIOGLITAZONE HYDROCHLORIDE		None (Tentative Approval)	No
			002	PIOGLITAZONE	TABLET; ORAL	30MG	PIOGLITAZONE HYDROCHLORIDE		None (Tentative Approval)	No
			003	PIOGLITAZONE	TABLET; ORAL	45MG	PIOGLITAZONE HYDROCHLORIDE		None (Tentative Approval)	No
008762	NDA	VIATRIS	001	DILANTIN-125	SUSPENSION;ORAL	125MG/5ML	PHENYTOIN	1953-01-06	Prescription	Yes
008762	NDA	VIATRIS	002	DILANTIN-30	SUSPENSION;ORAL	30MG/5ML	PHENYTOIN	1953-01-06	Discontinued	No