FDA.reportPublic FDA data

Application 201991

Type
ANDA
Sponsor
INVENTIA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8289METFORMIN HYDROCHLORIDEmetformin hydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8289METFORMIN HYDROCHLORIDEmetformin hydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0781-5503METFORMIN HYDROCHLORIDEmetformin hydrochlorideSANDOZ INC.ANDACurrent
10544-944Metformin hydrochlorideMetformin hydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
49252-001Metformin hydrochlorideMetformin hydrochlorideInventia Healthcare Private LimitedANDACurrent
50090-1494METFORMIN HYDROCHLORIDEmetformin hydrochlorideA-S Medication SolutionsANDACurrent
50090-1494METFORMIN HYDROCHLORIDEmetformin hydrochlorideA-S Medication SolutionsANDACurrent
55700-618METFORMIN HYDROCHLORIDEmetformin hydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
61919-450METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEDIRECT RXANDACurrent
61919-450METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEDirect_RxANDACurrent
61919-769METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEDirectRXANDACurrent
63187-779Metformin hydrochlorideMetformin hydrochlorideProficient Rx LPANDACurrent
63187-779Metformin hydrochlorideMetformin hydrochlorideProficient Rx LPANDACurrent
67296-1643METFORMIN HYDROCHLORIDEmetformin hydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1643METFORMIN HYDROCHLORIDEmetformin hydrochlorideRedPharm Drug, Inc.ANDACurrent
67877-159METFORMIN HYDROCHLORIDEmetformin hydrochlorideAscend Laboratories, LLCANDACurrent
67877-159METFORMIN HYDROCHLORIDEmetformin hydrochlorideAscend Laboratories, LLCANDACurrent
68071-1419Metformin hydrochlorideMetformin hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-2636METFORMIN HYDROCHLORIDEmetformin hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6780Metformin hydrochlorideMetformin hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0408METFORMIN HYDROCHLORIDEmetformin hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3260METFORMIN HYDROCHLORIDEmetformin hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3260METFORMIN HYDROCHLORIDEmetformin hydrochlorideREMEDYREPACK INC.ANDACurrent
71335-0886METFORMIN HYDROCHLORIDEmetformin hydrochlorideBryant Ranch PrepackANDACurrent
71335-0886METFORMIN HYDROCHLORIDEmetformin hydrochlorideBryant Ranch PrepackANDACurrent
71335-0886METFORMIN HYDROCHLORIDEmetformin hydrochlorideBryant Ranch PrepackANDACurrent
71610-457METFORMIN HYDROCHLORIDEmetformin hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-457METFORMIN HYDROCHLORIDEmetformin hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
75834-500METFORMIN HYDROCHLORIDEmetformin hydrochlorideNivagen Pharmaceuticals IncANDACurrent
75834-500Metformin hydrochlorideMetformin hydrochlorideNivagen Pharmaceuticals IncANDACurrent