Application 065485

Type: ANDA
Sponsor: BARR LABS INC

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 90MG BASE	No	No
003	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 135MG BASE	No	No
004	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 65MG BASE	No	No
005	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 115MG BASE	No	No
007	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 80MG BASE	No	No
008	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 105MG BASE	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-2133	Minocycline Hydrochloride	Minocycline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2133	Minocycline Hydrochloride	Minocycline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2133	Minocycline Hydrochloride	Minocycline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2133	Minocycline Hydrochloride	Minocycline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2134	Minocycline Hydrochloride	Minocycline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2134	Minocycline Hydrochloride	Minocycline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2134	Minocycline Hydrochloride	Minocycline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2134	Minocycline Hydrochloride	Minocycline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7741	Minocycline Hydrochloride	Minocycline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7741	Minocycline Hydrochloride	Minocycline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7742	Minocycline Hydrochloride	Minocycline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7742	Minocycline Hydrochloride	Minocycline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7742	Minocycline Hydrochloride	Minocycline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7742	Minocycline Hydrochloride	Minocycline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7743	Minocycline Hydrochloride	Minocycline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7743	Minocycline Hydrochloride	Minocycline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7743	Minocycline Hydrochloride	Minocycline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7743	Minocycline Hydrochloride	Minocycline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
50981	SUPPL	2018-01-08
48286	SUPPL	2017-05-09
48285	SUPPL	2017-05-09