FDA.reportPublic FDA data

Application 077880

Type
ANDA
Sponsor
AMNEAL PHARMS NY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDETABLET;ORAL500MGNoNo
002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDETABLET;ORAL850MGNoNo
003METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDETABLET;ORAL1GMNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-605Metformin HydrochlorideMetformin HydrochlorideAvKARE, Inc.ANDACurrent
42291-605Metformin HydrochlorideMetformin HydrochlorideAvKARE, Inc.ANDACurrent
42291-606Metformin HydrochlorideMetformin HydrochlorideAvKARE, Inc.ANDACurrent
42291-606Metformin HydrochlorideMetformin HydrochlorideAvKARE, Inc.ANDACurrent
42291-607Metformin HydrochlorideMetformin HydrochlorideAvKARE, Inc.ANDACurrent
42291-607Metformin HydrochlorideMetformin HydrochlorideAvKARE, Inc.ANDACurrent
43063-430Metformin HydrochlorideMetformin HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-430Metformin HydrochlorideMetformin HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-430Metformin HydrochlorideMetformin HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-430Metformin HydrochlorideMetformin HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-527Metformin HydrochlorideMetformin HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-527Metformin HydrochlorideMetformin HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-527Metformin HydrochlorideMetformin HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-527Metformin HydrochlorideMetformin HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-544Metformin HydrochlorideMetformin HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-544Metformin HydrochlorideMetformin HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-544Metformin HydrochlorideMetformin HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-544Metformin HydrochlorideMetformin HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43353-811Metformin HydrochlorideMetformin HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-842Metformin HydrochlorideMetformin HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-885Metformin HydrochlorideMetformin HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
53746-218Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
53746-218Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
53746-218Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
53746-219Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
53746-219Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
53746-219Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
53746-220Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
53746-220Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
53746-220Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
63739-640METFORMIN HYDROCHLORIDEMetformin HydrochlorideMcKesson CorporationANDACurrent
63739-640METFORMIN HYDROCHLORIDEMetformin HydrochlorideMcKesson Corporation dba SKY PackagingANDACurrent
63739-655METFORMIN HYDROCHLORIDEMetformin HydrochlorideMcKesson CorporationANDACurrent
63739-655METFORMIN HYDROCHLORIDEMetformin HydrochlorideMcKesson Corporation dba SKY PackagingANDACurrent
64205-218Metformin HydrochlorideMetformin HydrochlorideReadyMedsANDACurrent
64205-220Metformin HydrochlorideMetformin HydrochlorideReadyMedsANDACurrent
65162-174Metformin HydrochlorideMetforminAmneal PharmaceuticalsANDACurrent
65162-175Metformin HydrochlorideMetforminAmneal PharmaceuticalsANDACurrent
65162-177Metformin HydrochlorideMetforminAmneal PharmaceuticalsANDACurrent
65162-218Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-218Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-218Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-218Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-219Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-219Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-219Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-219Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-220Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-220Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-220Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-220Metformin HydrochlorideMetformin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent