FDA.reportPublic FDA data

Application 078596

Type
ANDA
Sponsor
AMNEAL PHARMS NY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL500MGNoNo
002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL750MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-535Metformin HydrochlorideMetformin HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
33261-372Metformin HydrochlorideMetformin HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
42291-497Metformin HydrochlorideMetformin HydrochlorideAvKAREANDACurrent
42291-497Metformin HydrochlorideMetformin HydrochlorideAvKAREANDACurrent
42291-498Metformin HydrochlorideMetformin HydrochlorideAvKAREANDACurrent
42291-610Metformin HydrochlorideMetformin HydrochlorideAvKARE, Inc.ANDACurrent
42291-610Metformin HydrochlorideMetformin HydrochlorideAvKARE, Inc.ANDACurrent
42291-610Metformin HydrochlorideMetformin HydrochlorideAvKARE, Inc.ANDACurrent
42291-610Metformin HydrochlorideMetformin HydrochlorideAvKARE, Inc.ANDACurrent
42291-610Metformin HydrochlorideMetformin HydrochlorideAvKAREANDACurrent
42291-610Metformin HydrochlorideMetformin HydrochlorideAvKAREANDACurrent
42291-611Metformin HydrochlorideMetformin HydrochlorideAvKARE, Inc.ANDACurrent
42291-611Metformin HydrochlorideMetformin HydrochlorideAvKAREANDACurrent
42291-611Metformin HydrochlorideMetformin HydrochlorideAvKARE, Inc.ANDACurrent
42291-611Metformin HydrochlorideMetformin HydrochlorideAvKARE, Inc.ANDACurrent
42291-611Metformin HydrochlorideMetformin HydrochlorideAvKARE, Inc.ANDACurrent
43063-428Metformin HydrochlorideMetformin HydrochloridePD-Rx Pharmaceuticals, InANDACurrent
43063-428Metformin HydrochlorideMetformin HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-428Metformin HydrochlorideMetformin HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
50268-531Metformin HydrochlorideMetformin HydrochlorideAvPAKANDACurrent
50268-531Metformin HydrochlorideMetformin HydrochlorideAvPAKANDACurrent
50268-531Metformin HydrochlorideMetformin HydrochlorideAvPAKANDACurrent
50268-532Metformin HydrochlorideMetformin HydrochlorideAvPAKANDACurrent
53746-178Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
53746-178Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
53746-178Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
53746-179Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
53746-179Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
53746-179Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
65162-178Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-178Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-178Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-178Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-178Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-179Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-179Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-179Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-179Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-179Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
68084-072Metformin HydrochlorideMetformin HydrochlorideAmerican Health PackagingANDACurrent
68151-4218Metformin HydrochlorideMetformin HydrochlorideCarilion Materials ManagementANDACurrent
69238-2125Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-2126Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
71610-020Metformin HydrochlorideMetformin HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-020Metformin HydrochlorideMetformin HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-304Metformin HydrochlorideMetformin HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-652Metformin HydrochlorideMetformin HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent