Application 078321

Type: ANDA
Sponsor: CSPC OUYI

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	500MG	No	No
002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	750MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-2767	Metformin Hydrochloride	Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2767	Metformin Hydrochloride	Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3719	Metformin Hydrochloride	Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3719	Metformin Hydrochloride	Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3719	Metformin Hydrochloride	Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4884	Metformin Hydrochloride	Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
50268-550	Metformin Hydrochloride	Metformin Hydrochloride	AvPAK	ANDA	Current
50268-551	Metformin Hydrochloride	Metformin Hydrochloride	AvPAK	ANDA	Current
50268-551	Metformin Hydrochloride	Metformin Hydrochloride	AvPAK	ANDA	Current
50436-0700	Metformin Hydrochloride	Metformin Hydrochloride	Unit Dose Services	ANDA	Current
51224-007	Metformin Hydrochloride	Metformin Hydrochloride	TAGI Pharma, Inc.	ANDA	Current
51224-007	Metformin Hydrochloride	Metformin Hydrochloride	TAGI Pharma, Inc.	ANDA	Current
51224-107	Metformin Hydrochloride	Metformin Hydrochloride	TAGI Pharma, Inc.	ANDA	Current
51224-107	Metformin Hydrochloride	Metformin Hydrochloride	TAGI Pharma, Inc.	ANDA	Current
51655-368	Metformin Hydrochloride	Metformin Hydrochloride	Northwind Pharmaceuticals	ANDA	Current
51655-368	Metformin Hydrochloride	Metformin Hydrochloride	Northwind Pharmaceuticals	ANDA	Current
55700-734	Metformin Hydrochloride	Metformin Hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-734	Metformin Hydrochloride	Metformin Hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-734	Metformin Hydrochloride	Metformin Hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-734	Metformin Hydrochloride	Metformin Hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-734	Metformin Hydrochloride	Metformin Hydrochloride	Quality Care Products, LLC	ANDA	Current
63629-8166	Metformin Hydrochloride	Metformin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8166	Metformin Hydrochloride	Metformin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
67296-1701	Metformin Hydrochloride	Metformin Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1701	Metformin Hydrochloride	Metformin Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
68071-4270	Metformin Hydrochloride	Metformin Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4270	Metformin Hydrochloride	Metformin Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7204	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7204	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7204	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7204	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7204	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7205	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7205	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7205	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7205	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7205	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0512	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0512	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0512	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0512	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0512	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0512	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0512	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0512	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0844	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0844	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0844	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0844	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2709	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2709	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2709	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2709	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70934-083	Metformin Hydrochloride	Metformin Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-083	Metformin Hydrochloride	Metformin Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-083	Metformin Hydrochloride	Metformin Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-083	Metformin Hydrochloride	Metformin Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-117	Metformin Hydrochloride	Metformin Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-117	Metformin Hydrochloride	Metformin Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-117	Metformin Hydrochloride	Metformin Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-134	Metformin Hydrochloride	Metformin Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-134	Metformin Hydrochloride	Metformin Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-141	Metformin Hydrochloride	Metformin Hydrochloride	Proficient Rx LP	ANDA	Current
71205-141	Metformin Hydrochloride	Metformin Hydrochloride	Proficient Rx LP	ANDA	Current
71205-186	Metformin Hydrochloride	Metformin Hydrochloride	Proficient Rx LP	ANDA	Current
71205-186	Metformin Hydrochloride	Metformin Hydrochloride	Proficient Rx LP	ANDA	Current
71205-186	Metformin Hydrochloride	Metformin Hydrochloride	Proficient Rx LP	ANDA	Current
71205-186	Metformin Hydrochloride	Metformin Hydrochloride	Proficient Rx LP	ANDA	Current
71335-0720	Metformin Hydrochloride	Metformin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0720	Metformin Hydrochloride	Metformin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0776	Metformin Hydrochloride	Metformin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0776	Metformin Hydrochloride	Metformin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71610-533	Metformin Hydrochloride	Metformin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-533	Metformin Hydrochloride	Metformin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
72189-150	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	direct rx	ANDA	Current
72189-150	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	direct rx	ANDA	Current
72189-150	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	direct rx	ANDA	Current
72789-059	Metformin Hydrochloride	Metformin Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-059	Metformin Hydrochloride	Metformin Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-059	Metformin Hydrochloride	Metformin Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current

Application 078321

Related Records#

Application Products#

NDC Listings For This Application#