FDA.reportPublic FDA data

Application 075042

Type
ANDA
Sponsor
TARO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCORTISONE VALERATEHYDROCORTISONE VALERATECREAM;TOPICAL0.2%NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0713-0668Hydrocortisone ValerateHydrocortisone ValerateG&W Laboratories, Inc.ANDACurrent
0713-0668Hydrocortisone ValerateHydrocortisone ValerateCosette Pharmaceuticals, Inc.ANDACurrent
0713-0668Hydrocortisone ValerateHydrocortisone ValerateCosette Pharmaceuticals, Inc.ANDACurrent
21695-730Hydrocortisone ValerateHydrocortisone ValerateRebel Distributors CorpANDACurrent
51672-1290Hydrocortisone ValerateHydrocortisone ValerateTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-1290Hydrocortisone ValerateHydrocortisone ValerateTaro Pharmaceuticals U.S.A., Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39452ORIG2004-06-07
22405ORIG2003-08-05
30738ORIG1998-08-25