Application 091424

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 45MG BASE	No	No
002	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 55MG BASE	No	No
003	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 90MG BASE	No	No
004	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 135MG BASE	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68180-379	Minocycline Hydrochloride	Minocycline Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-379	Minocycline Hydrochloride	Minocycline Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-379	Minocycline Hydrochloride	Minocycline Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-380	Minocycline Hydrochloride	Minocycline Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-380	Minocycline Hydrochloride	Minocycline Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-380	Minocycline Hydrochloride	Minocycline Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-381	Minocycline Hydrochloride	Minocycline Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-381	Minocycline Hydrochloride	Minocycline Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-381	Minocycline Hydrochloride	Minocycline Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-460	Minocycline Hydrochloride	Minocycline Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-460	Minocycline Hydrochloride	Minocycline Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-460	Minocycline Hydrochloride	Minocycline Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
50982	ORIG	2018-01-08