Application 020215

Type: NDA
Sponsor: LANNETT CO INC

Related Records

Company: LANNETT CO INC

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MONOKET	ISOSORBIDE MONONITRATE	TABLET;ORAL	20MG	Yes	Yes
002	MONOKET	ISOSORBIDE MONONITRATE	TABLET;ORAL	10MG	Yes	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62175-106	isosorbide mononitrate	isosorbide mononitrate	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
62175-106	isosorbide mononitrate	isosorbide mononitrate	Lannett Company, Inc..	NDA AUTHORIZED GENERIC	Current
62175-106	isosorbide mononitrate	isosorbide mononitrate	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
62175-107	isosorbide mononitrate	isosorbide mononitrate	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
62175-107	isosorbide mononitrate	isosorbide mononitrate	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
62175-107	isosorbide mononitrate	isosorbide mononitrate	Lannett Company, Inc..	NDA AUTHORIZED GENERIC	Current
62175-361	Monoket	isosorbide mononitrate	Kremers Urban Pharmaceuticals Inc.	NDA	Current
62175-361	Monoket	isosorbide mononitrate	Lannett Company, Inc.	NDA	Current
62175-362	Monoket	isosorbide mononitrate	Kremers Urban Pharmaceuticals Inc.	NDA	Current
62175-362	Monoket	isosorbide mononitrate	Lannett Company, Inc.	NDA	Current
63187-900	isosorbide mononitrate	isosorbide mononitrate	Proficient Rx LP	NDA AUTHORIZED GENERIC	Current
63187-900	isosorbide mononitrate	isosorbide mononitrate	Proficient Rx LP	NDA AUTHORIZED GENERIC	Current
68151-0314	isosorbide mononitrate	isosorbide mononitrate	Carilion Materials Management	NDA AUTHORIZED GENERIC	Current
70518-2000	isosorbide mononitrate	isosorbide mononitrate	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2000	isosorbide mononitrate	isosorbide mononitrate	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2000	isosorbide mononitrate	isosorbide mononitrate	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2000	isosorbide mononitrate	isosorbide mononitrate	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2206	isosorbide mononitrate	isosorbide mononitrate	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2206	isosorbide mononitrate	isosorbide mononitrate	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2206	isosorbide mononitrate	isosorbide mononitrate	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current

Documents

Document	Submission type	Date
70071	SUPPL	2022-02-04
34377	SUPPL	2014-10-03
2173	SUPPL	2014-10-03