Application 090564

Type: ANDA
Sponsor: GRANULES INDIA

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	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6689	Metformin hydrochloride	Metformin hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6689	Metformin hydrochloride	Metformin hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6689	Metformin hydrochloride	Metformin hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6690	Metformin hydrochloride	Metformin hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6690	Metformin hydrochloride	Metformin hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6690	Metformin hydrochloride	Metformin hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6691	Metformin hydrochloride	Metformin hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6691	Metformin hydrochloride	Metformin hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6691	Metformin hydrochloride	Metformin hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7162	Metformin Hydrochloride	Metformin Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7163	Metformin Hydrochloride	Metformin Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7164	Metformin Hydrochloride	Metformin Hydrochloride	Major Pharmaceuticals	ANDA	Current
10544-133	Metformin Hydrochloride	Metformin Hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
10544-254	Metformin Hydrochloride	Metformin Hydrochloride	Blenheim Pharmacal Inc.	ANDA	Current
10544-589	Metformin Hydrochloride	Metformin Hydrochloride	Blenheim Pharmacal Inc.	ANDA	Current
10544-947	Metformin Hydrochloride	Metformin Hydrochloride	Blenheim Pharmacal Inc.	ANDA	Current
23155-102	metformin hydrochloride	metformin hydrochloride	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-102	metformin hydrochloride	metformin hydrochloride	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-102	metformin hydrochloride	metformin hydrochloride	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-103	metformin hydrochloride	metformin hydrochloride	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-103	metformin hydrochloride	metformin hydrochloride	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-103	metformin hydrochloride	metformin hydrochloride	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-104	metformin hydrochloride	metformin hydrochloride	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-104	metformin hydrochloride	metformin hydrochloride	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-104	metformin hydrochloride	metformin hydrochloride	Heritage Pharmaceuticals Inc.	ANDA	Current
42708-009	Metformin HCl	Metformin HCl	QPharma Inc	ANDA	Current
42708-009	Metformin HCl	Metformin HCl	QPharma Inc	ANDA	Current
42708-009	Metformin HCl	Metformin HCl	QPharma Inc	ANDA	Current
42708-018	Metformin HCl	Metformin HCl	QPharma Inc	ANDA	Current
42708-018	Metformin HCl	Metformin HCl	QPharma Inc	ANDA	Current
42708-018	Metformin HCl	Metformin HCl	QPharma Inc	ANDA	Current
42806-313	Metformin Hydrochloride	Metformin Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-313	Metformin Hydrochloride	Metformin Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-314	Metformin Hydrochloride	Metformin Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-314	Metformin Hydrochloride	Metformin Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-315	Metformin Hydrochloride	Metformin Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-315	Metformin Hydrochloride	Metformin Hydrochloride	Epic Pharma, LLC	ANDA	Current
43063-889	Metformin hydrochloride	Metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-889	metformin hydrochloride	metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-889	metformin hydrochloride	metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-889	metformin hydrochloride	metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-889	metformin hydrochloride	metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-889	metformin hydrochloride	metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-889	metformin hydrochloride	metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-889	metformin hydrochloride	metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-889	metformin hydrochloride	metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-898	Metformin hydrochloride	Metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-898	metformin hydrochloride	metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-898	metformin hydrochloride	metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-898	metformin hydrochloride	metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-898	metformin hydrochloride	metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-898	metformin hydrochloride	metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-898	metformin hydrochloride	metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
45865-517	Metformin hydrochloride	Metformin hydrochloride	Medsource Pharmaceuticals	ANDA	Current
49999-116	metformin hydrochloride	metformin hydrochloride	Quality Care Products, LLC	ANDA	Current
50090-0766	metformin hydrochloride	metformin hydrochloride	A-S Medication Solutions	ANDA	Current
50090-0766	Metformin hydrochloride	Metformin hydrochloride	A-S Medication Solutions	ANDA	Current
50090-0766	metformin hydrochloride	metformin hydrochloride	A-S Medication Solutions	ANDA	Current
50090-0766	metformin hydrochloride	metformin hydrochloride	A-S Medication Solutions	ANDA	Current
50090-0769	Metformin hydrochloride	Metformin hydrochloride	A-S Medication Solutions	ANDA	Current
50090-0775	Metformin hydrochloride	Metformin hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3050	Metformin HCl	Metformin HCl	A-S Medication Solutions	ANDA	Current
50090-3050	Metformin HCl	Metformin HCl	A-S Medication Solutions	ANDA	Current
50090-3050	Metformin HCl	Metformin HCl	A-S Medication Solutions	ANDA	Current
50090-3050	Metformin HCl	Metformin HCl	A-S Medication Solutions	ANDA	Current
50090-3064	Metformin HCl	Metformin HCl	A-S Medication Solutions	ANDA	Current
50090-3064	Metformin HCl	Metformin HCl	A-S Medication Solutions	ANDA	Current
50090-3579	Metformin HCl	Metformin HCl	A-S Medication Solutions	ANDA	Current
50090-3579	Metformin HCl	Metformin HCl	A-S Medication Solutions	ANDA	Current
50090-3579	Metformin HCl	Metformin HCl	A-S Medication Solutions	ANDA	Current
50090-3579	Metformin HCl	Metformin HCl	A-S Medication Solutions	ANDA	Current
50090-4891	Metformin HCl	Metformin HCl	A-S Medication Solutions	ANDA	Current
50090-4892	Metformin HCl	Metformin HCl	A-S Medication Solutions	ANDA	Current
50090-4943	metformin hydrochloride	metformin hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4973	metformin hydrochloride	metformin hydrochloride	A-S Medication Solutions	ANDA	Current
50436-9054	Metformin hydrochloride	Metformin hydrochloride	Unit Dose Services	ANDA	Current
50436-9054	Metformin hydrochloride	metformin hydrochloride	Unit Dose Services	ANDA	Current
50436-9055	Metformin hydrochloride	Metformin hydrochloride	Unit Dose Services	ANDA	Current
50436-9056	Metformin hydrochloride	Metformin hydrochloride	Unit Dose Services	ANDA	Current
50742-154	Metformin hydrochloride	Metformin hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current

Application 090564

Related Records#

Application Products#

NDC Listings For This Application#