FDA.reportPublic FDA data

Application 205096

Type
ANDA
Sponsor
CSPC OUYI

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
50090-4412Metformin HydrochlorideMetformin HydrochlorideA-S Medication SolutionsANDACurrent
51224-020Metformin HydrochlorideMetformin HydrochlorideTAGI Pharma, Inc.ANDACurrent
51224-120Metformin HydrochlorideMetformin HydrochlorideTAGI Pharma, Inc.ANDACurrent
51224-220Metformin HydrochlorideMetformin HydrochlorideTAGI Pharma, Inc.ANDACurrent
70518-3212Metformin HydrochlorideMetformin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3212Metformin HydrochlorideMetformin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3212Metformin HydrochlorideMetformin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3212Metformin HydrochlorideMetformin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3611Metformin HydrochlorideMetformin HydrochlorideREMEDYREPACK INC.ANDACurrent
70934-311METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-399METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-399METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-1288Metformin HydrochlorideMetformin HydrochlorideBryant Ranch PrepackANDACurrent
71335-1288Metformin HydrochlorideMetformin HydrochlorideBryant Ranch PrepackANDACurrent
71335-1288Metformin HydrochlorideMetformin HydrochlorideBryant Ranch PrepackANDACurrent
71335-1289Metformin HydrochlorideMetformin HydrochlorideBryant Ranch PrepackANDACurrent
71335-1289Metformin HydrochlorideMetformin HydrochlorideBryant Ranch PrepackANDACurrent
71335-1303Metformin HydrochlorideMetformin HydrochlorideBryant Ranch PrepackANDACurrent
71335-1303Metformin HydrochlorideMetformin HydrochlorideBryant Ranch PrepackANDACurrent
71610-210METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-278METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCANDACurrent
71717-104METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEMegalith Pharmaceuticals IncANDACurrent
71717-105METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEMegalith Pharmaceuticals IncANDACurrent
71717-106METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEMegalith Pharmaceuticals IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10422ORIG2016-07-13