FDA.reportPublic FDA data

Application 213334

Type
ANDA
Sponsor
SCIEGEN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL500MGNoNo
002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL1GMNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50228-445Metformin HydrochlorideMetformin Hydrochloride Extended-Release TabletsScieGen Pharmaceuticals, Inc.ANDACurrent
50228-445Metformin HydrochlorideMetformin Hydrochloride Extended-Release TabletsScieGen Pharmaceuticals, Inc.ANDACurrent
50228-446Metformin HydrochlorideMetformin Hydrochloride Extended-Release TabletsScieGen Pharmaceuticals, Inc.ANDACurrent
50228-446Metformin HydrochlorideMetformin Hydrochloride Extended-Release TabletsScieGen Pharmaceuticals, Inc.ANDACurrent
73317-4256METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDESLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALSANDACurrent
73317-4258METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDESLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALSANDACurrent