FDA.reportPublic FDA data

Application 090295

Type
ANDA
Sponsor
MARKSANS PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL500MGNoNo
002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL750MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
25000-101Metformin HydrochlorideMetformin HydrochlorideMARKSANS PHARMA LIMITEDANDACurrent
25000-101Metformin HydrochlorideMetformin HydrochlorideMARKSANS PHARMA LIMITEDANDACurrent
25000-102Metformin HydrochlorideMetformin HydrochlorideMARKSANS PHARMA LIMITEDANDACurrent
25000-102Metformin HydrochlorideMetformin HydrochlorideMARKSANS PHARMA LIMITEDANDACurrent
43063-902METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-902METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-902METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-902METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-902METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-902METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-902METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
49483-623METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDETIME CAP LABORATORIES, INCANDACurrent
49483-623METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDETIME CAP LABORATORIES, INCANDACurrent
49483-624METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDETIME CAP LABORATORIES, INCANDACurrent
49483-624METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDETIME CAP LABORATORIES, INCANDACurrent
60760-623METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDESt. Marys Medical Park PharmacyANDACurrent
61919-922METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEDIRECT RXANDACurrent
61919-922METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEDIRECT RXANDACurrent
68071-3111METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals, Inc.ANDACurrent
68071-3111METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals, Inc.ANDACurrent
68788-6932METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.ANDACurrent
68788-6932METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.ANDACurrent
68788-6932METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.ANDACurrent
68788-6932METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.ANDACurrent
68788-7337METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.ANDACurrent
68788-7337METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.ANDACurrent
68788-8225METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEPreferred PHarmaceuticals Inc.ANDACurrent
70518-0899METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-0899METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-2480METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-2480METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-2480METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-2480METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-2480METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70934-309METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-334METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0293METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-0293METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-0889METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-0889METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-0889METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-1310METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71610-454METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-454METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCANDACurrent
72189-064METFORMIN HYDROCHLORIDE EXTENDED RELEASEmetformin hydrochloridedirect rxANDACurrent
72189-064METFORMIN HYDROCHLORIDE EXTENDED RELEASEmetformin hydrochloridedirect rxANDACurrent
72189-064METFORMIN HYDROCHLORIDE EXTENDED RELEASEmetformin hydrochloridedirect rxANDACurrent
72189-064METFORMIN HYDROCHLORIDE EXTENDED RELEASEmetformin hydrochloridedirect rxANDACurrent
72789-009METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-009METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-009METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-009METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent