Application 209303

Type
ANDA
Sponsor
ALIGNSCIENCE PHARMA

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
69948-001Metformin HydrochlorideMetformin HydrochlorideAlignScience Pharma Inc.ANDACurrent
69948-001Metformin HydrochlorideMetformin HydrochlorideAlignScience Pharma Inc.ANDACurrent