Application 203553

Type: ANDA
Sponsor: ZYDUS PHARMS

Related Records

Company: ZYDUS PHARMS

Application Products

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

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68382-531	minocycline hydrochloride	minocycline hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-531	minocycline hydrochloride	minocycline hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-533	minocycline hydrochloride	minocycline hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-533	minocycline hydrochloride	minocycline hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-535	minocycline hydrochloride	minocycline hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-535	minocycline hydrochloride	minocycline hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-551	minocycline hydrochloride	minocycline hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-551	minocycline hydrochloride	minocycline hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-552	minocycline hydrochloride	minocycline hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-552	minocycline hydrochloride	minocycline hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1138	minocycline hydrochloride	minocycline hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1138	minocycline hydrochloride	minocycline hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1155	minocycline hydrochloride	minocycline hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1155	minocycline hydrochloride	minocycline hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1156	minocycline hydrochloride	minocycline hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1156	minocycline hydrochloride	minocycline hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1157	minocycline hydrochloride	minocycline hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1157	minocycline hydrochloride	minocycline hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1167	minocycline hydrochloride	minocycline hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1167	minocycline hydrochloride	minocycline hydrochloride	Cadila Healthcare Limited	ANDA	Current

Documents

Document	Submission type	Date
50727	ORIG	2017-12-18