Application 202101

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

Related Records

Company: ALEMBIC PHARMS LTD

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ARIPIPRAZOLE	ARIPIPRAZOLE	TABLET;ORAL	2MG	No	No
002	ARIPIPRAZOLE	ARIPIPRAZOLE	TABLET;ORAL	5MG	No	No
003	ARIPIPRAZOLE	ARIPIPRAZOLE	TABLET;ORAL	10MG	No	No
004	ARIPIPRAZOLE	ARIPIPRAZOLE	TABLET;ORAL	15MG	No	No
005	ARIPIPRAZOLE	ARIPIPRAZOLE	TABLET;ORAL	20MG	No	No
006	ARIPIPRAZOLE	ARIPIPRAZOLE	TABLET;ORAL	30MG	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13811-679	Aripiprazole	Aripiprazole	Trigen Laboratories, LLC	ANDA	Current
13811-680	Aripiprazole	Aripiprazole	Trigen Laboratories, LLC	ANDA	Current
13811-681	Aripiprazole	Aripiprazole	Trigen Laboratories, LLC	ANDA	Current
13811-682	Aripiprazole	Aripiprazole	Trigen Laboratories, LLC	ANDA	Current
13811-683	Aripiprazole	Aripiprazole	Trigen Laboratories, LLC	ANDA	Current
13811-684	Aripiprazole	Aripiprazole	Trigen Laboratories, LLC	ANDA	Current
17856-0680	Aripiprazole	Aripiprazole	Atlantic Biologicals Corps	ANDA	Current
17856-0680	Aripiprazole	Aripiprazole	Atlantic Biologicals Corps	ANDA	Current
46708-254	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Limited	ANDA	Current
46708-254	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Limited	ANDA	Current
46708-255	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Limited	ANDA	Current
46708-255	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Limited	ANDA	Current
46708-256	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Limited	ANDA	Current
46708-256	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Limited	ANDA	Current
46708-257	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Limited	ANDA	Current
46708-257	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Limited	ANDA	Current
46708-258	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Limited	ANDA	Current
46708-258	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Limited	ANDA	Current
46708-259	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Limited	ANDA	Current
46708-259	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Limited	ANDA	Current
62332-097	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-097	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-097	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-097	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-097	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-098	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-098	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-098	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-098	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-098	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-099	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-099	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-099	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-099	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-099	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-100	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-100	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-100	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-100	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-100	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-101	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-101	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-101	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-101	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-101	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-102	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-102	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-102	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-102	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-102	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
68151-4459	Aripiprazole	Aripiprazole	Carilion Materials Management	ANDA	Current
70518-1794	Aripiprazole	Aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-1794	Aripiprazole	Aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-1822	Aripiprazole	Aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-1822	Aripiprazole	Aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-1870	Aripiprazole	Aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-1871	Aripiprazole	Aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2149	Aripiprazole	Aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2150	Aripiprazole	Aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2281	Aripiprazole	Aripiprazole	REMEDYREPACK INC.	ANDA	Current

Documents

Document	Submission type	Date
40120	ORIG	2015-04-29
9960	ORIG	2015-04-29