Application 077095

Type: ANDA
Sponsor: AUROBINDO

Related Records

Company: AUROBINDO

Application Products

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	Labeler	Marketing category	Status
0179-1979	Metformin Hydrochloride	Metformin Hydrochloride	KAISER FOUNDATION HOSPITALS	ANDA	Current
0615-7982	Metformin Hydrochloride	Metformin Hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-7982	Metformin Hydrochloride	Metformin Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7982	Metformin Hydrochloride	Metformin Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8015	Metformin Hydrochloride	Metformin Hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8015	Metformin Hydrochloride	Metformin Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8015	Metformin Hydrochloride	Metformin Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8105	Metformin Hydrochoride	Metformin	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8105	Metformin Hydrochoride	Metformin	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8105	Metformin Hydrochoride	Metformin	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
35356-886	Metformin Hydrochloride	Metformin Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-886	Metformin Hydrochloride	Metformin Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-886	Metformin Hydrochloride	Metformin Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-922	Metformin Hydrochloride	Metformin Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-922	Metformin Hydrochloride	Metformin Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
42708-039	Metformin Hydrochloride	Metformin Hydrochloride	QPharma Inc	ANDA	Current
42708-039	Metformin Hydrochloride	Metformin Hydrochloride	QPharma Inc	ANDA	Current
42708-040	Metformin Hydrochloride	Metformin Hydrochloride	QPharma Inc	ANDA	Current
42708-040	Metformin Hydrochloride	Metformin Hydrochloride	QPharma Inc	ANDA	Current
43353-114	Metformin Hydrochloride	Metformin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
49999-106	Metformin Hydrochloride	Metformin Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
49999-106	Metformin Hydrochloride	Metformin Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
49999-106	Metformin Hydrochloride	Metformin Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
50090-2173	Metformin Hydrochloride	Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2173	Metformin Hydrochloride	Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2177	Metformin Hydrochloride	Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2177	Metformin Hydrochloride	Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
53808-0459	Metformin Hydrochloride	Metformin Hydrochloride	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0848	Metformin Hydrochloride	Metformin Hydrochloride	State of Florida DOH Central Pharmacy	ANDA	Current
63187-238	Metformin Hydrochloride	Metformin Hydrochloride	Proficient Rx LP	ANDA	Current
63187-238	Metformin Hydrochloride	Metformin Hydrochloride	Proficient Rx LP	ANDA	Current
63187-239	Metformin Hydrochloride	Metformin Hydrochloride	Proficient Rx LP	ANDA	Current
63187-239	Metformin Hydrochloride	Metformin Hydrochloride	Proficient Rx LP	ANDA	Current
63629-6529	Metformin Hydrochloride	Metformin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-6530	Metformin Hydrochloride	Metformin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-6530	Metformin Hydrochloride	Metformin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
65862-008	Metformin Hydrochloride	Metformin Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-008	Metformin Hydrochloride	Metformin Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-008	Metformin Hydrochloride	Metformin Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-008	Metformin Hydrochloride	Metformin Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-009	Metformin Hydrochloride	Metformin Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-009	Metformin Hydrochloride	Metformin Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-009	Metformin Hydrochloride	Metformin Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-009	Metformin Hydrochloride	Metformin Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-010	Metformin Hydrochloride	Metformin Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-010	Metformin Hydrochloride	Metformin Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-010	Metformin Hydrochloride	Metformin Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-010	Metformin Hydrochloride	Metformin Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
67296-0559	Metformin Hydrochloride	Metformin Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-0700	Metformin Hydrochloride	Metformin Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-0700	Metformin Hydrochloride	Metformin Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-0700	Metformin Hydrochloride	Metformin Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
68071-3212	Metformin Hydrochloride	Metformin Hydrochloride	NuCare Pharmarmaceuticals, Inc.	ANDA	Current
68071-3212	Metformin Hydrochloride	Metformin Hydrochloride	NuCare Pharmarmaceuticals, Inc.	ANDA	Current
68645-300	Metformin Hydrochloride	Metformin Hydrochloride	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-300	Metformin Hydrochloride	Metformin Hydrochloride	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-300	Metformin Hydrochloride	Metformin Hydrochloride	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-300	Metformin Hydrochloride	Metformin Hydrochloride	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
70518-1149	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1149	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1149	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1149	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3130	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3130	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70934-066	Metformin Hydrochloride	Metformin Hydrochloride	Denton Pharma, Inc.	ANDA	Current
70934-066	Metformin Hydrochloride	Metformin Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-066	Metformin Hydrochloride	Metformin Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71455-104	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	UNYTER ENTERPRISES	ANDA	Current