FDA.reportPublic FDA data

Application 202917

Type
ANDA
Sponsor
SUN PHARM

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
16714-938Metformin HydrochlorideMetformin HydrochlorideNorthStar RxLLCANDACurrent
16714-939Metformin HydrochlorideMetformin HydrochlorideNorthStar RxLLCANDACurrent
47335-305Metformin HydrochlorideMetformin HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-305Metformin HydrochlorideMetformin HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-305Metformin HydrochlorideMetformin HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-306Metformin HydrochlorideMetformin HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-306Metformin HydrochlorideMetformin HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-306Metformin HydrochlorideMetformin HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent