Application 210209

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCORTISONE BUTYRATEHYDROCORTISONE BUTYRATELOTION;TOPICAL0.1%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68180-951Hydrocortisone ButyrateHydrocortisone ButyrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-951Hydrocortisone ButyrateHydrocortisone ButyrateLupin Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
52802ORIG2018-03-02