FDA.reportPublic FDA data

Application 075043

Type
ANDA
Sponsor
TARO

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0713-0669Hydrocortisone ValerateHYDROCORTISONE VALERATECosette Pharmaceuticals, Inc.ANDACurrent
0713-0669Hydrocortisone ValerateHYDROCORTISONE VALERATECosette Pharmaceuticals, Inc.ANDACurrent
0713-0669Hydrocortisone ValerateHYDROCORTISONE VALERATEG&W Laboratories, Inc.ANDACurrent
51672-1292Hydrocortisone ValerateHydrocortisone ValerateTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-1292Hydrocortisone ValerateHydrocortisone ValerateTaro Pharmaceuticals U.S.A., Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18382ORIG2004-06-07
30739ORIG1998-08-25
22406ORIG1998-08-25