Application 077064

Type: ANDA
Sponsor: ZYDUS PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET;ORAL	500MG	No	No
002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET;ORAL	850MG	No	No
003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET;ORAL	1GM	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-901	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Blenheim Pharmacal, Inc.	ANDA	Current
43063-507	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, In	ANDA	Current
43063-507	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-507	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43353-098	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-098	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
53808-0849	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	State of Florida DOH Central Pharmacy	ANDA	Current
65841-028	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-028	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-028	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-028	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-028	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Lifesciences Limited	ANDA	Current
65841-028	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-029	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Lifesciences Limited	ANDA	Current
65841-029	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-029	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-029	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-029	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-029	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-030	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-030	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-030	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-030	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-030	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Lifesciences Limited	ANDA	Current
65841-030	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
67046-460	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Contract Pharmacy Services-PA	ANDA	Current
67046-461	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Contract Pharmacy Services-PA	ANDA	Current
67046-462	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Contract Pharmacy Services-PA	ANDA	Current
68382-028	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-028	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-029	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-029	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-030	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-030	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current

Application 077064

Related Records#

Application Products#

NDC Listings For This Application#