Application 202145

Type
ANDA
Sponsor
GLENMARK GENERICS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCORTISONE BUTYRATEHYDROCORTISONE BUTYRATECREAM;TOPICAL0.1%NoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
68462-464Hydrocortisone ButyrateHydrocortisone ButyrateGlenmark Pharmaceuticals Inc., USAANDACurrent

Documents

DocumentSubmission typeDate
19070ORIG2013-10-02
9973ORIG2013-10-01