FDA.reportPublic FDA data

Application 211052

Type
ANDA
Sponsor
YICHANG HUMANWELL

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
42806-632METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEEpic Pharma, LLCANDACurrent
42806-632METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEEpic Pharma, LLCANDACurrent
42806-632METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEEpic Pharma, LLCANDACurrent
42806-633METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEEpic Pharma, LLCANDACurrent
42806-633METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEEpic Pharma, LLCANDACurrent
42806-633METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEEpic Pharma, LLCANDACurrent
70436-052METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDESlate Run Pharmaceuticals, LLCANDACurrent
70436-053METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDESlate Run Pharmaceuticals, LLCANDACurrent
71610-586METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCANDACurrent