FDA.reportPublic FDA data

Application 209313

Type
ANDA
Sponsor
GRANULES INDIA LTD

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
62207-491Metformin ER 500 mgMetformin ER 500 mgGranules India LtdANDACurrent
62207-491Metformin ER 500 mgMetformin ER 500 mgGranules India LtdANDACurrent
62207-491Metformin ER 500 mgMetformin ER 500 mgGranules India LtdANDACurrent
62207-491Metformin ER 500 mgMetformin ER 500 mgGranules India LtdANDACurrent
62207-491Metformin ER 500 mgMetformin ER 500 mgGranules India LtdANDACurrent
62207-491Metformin ER 500 mgMetformin ER 500 mgGranules India LtdANDACurrent
62207-492Metformin ER 750 mgMetformin ER 750 mgGranules India LtdANDACurrent
62207-492Metformin ER 750 mgMetformin ER 750 mgGranules India LtdANDACurrent
62207-492Metformin ER 750 mgMetformin ER 750 mgGranules India LtdANDACurrent
62207-492Metformin ER 750 mgMetformin ER 750 mgGranules India LtdANDACurrent
62207-492Metformin ER 750 mgMetformin ER 750 mgGranules India LtdANDACurrent
62207-492Metformin ER 750 mgMetformin ER 750 mgGranules India LtdANDACurrent
68071-2779MetforminMetformin ER 500 mgNuCare Pharmaceuticals,Inc.ANDACurrent
68645-595MetforminMetformin ER 500 mgLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-595MetforminMetformin ER 500 mgLegacy Pharmaceutical Packaging, LLCANDACurrent
70010-491MetforminMetformin ER 500 mgGranules Pharmaceuticals Inc.ANDACurrent
70010-491MetforminMetformin ER 500 mgGranules Pharmaceuticals Inc.ANDACurrent
70010-491MetforminMetformin ER 500 mgGranules Pharmaceuticals Inc.ANDACurrent
70010-491MetforminMetformin ER 500 mgGranules Pharmaceuticals Inc.ANDACurrent
70010-491MetforminMetformin ER 500 mgGranules Pharmaceuticals Inc.ANDACurrent
70010-491MetforminMetformin ER 500 mgGranules Pharmaceuticals Inc.ANDACurrent
70010-491MetforminMetformin ER 500 mgGranules Pharmaceuticals Inc.ANDACurrent
70010-491MetforminMetformin ER 500 mgGranules Pharmaceuticals Inc.ANDACurrent
70010-492MetforminMetformin ER 750 mgGranules Pharmaceuticals Inc.ANDACurrent
70010-492MetforminMetformin ER 750 mgGranules Pharmaceuticals Inc.ANDACurrent
70010-492MetforminMetformin ER 750 mgGranules Pharmaceuticals Inc.ANDACurrent
70010-492MetforminMetformin ER 750 mgGranules Pharmaceuticals Inc.ANDACurrent
70010-492MetforminMetformin ER 750 mgGranules Pharmaceuticals Inc.ANDACurrent
70010-492MetforminMetformin ER 750 mgGranules Pharmaceuticals Inc.ANDACurrent
70010-492MetforminMetformin ER 750 mgGranules Pharmaceuticals Inc.ANDACurrent
70010-492MetforminMetformin ER 750 mgGranules Pharmaceuticals Inc.ANDACurrent
70518-3570MetforminMetformin ER 500 mgREMEDYREPACK INC.ANDACurrent
70518-3570MetforminMetformin ER 500 mgREMEDYREPACK INC.ANDACurrent
71610-613MetforminMetformin ER 500 mgAphena Pharma Solutions - Tennessee, LLCANDACurrent