FDA.reportPublic FDA data

Application 078162

Type
ANDA
Sponsor
ACP NIMBLE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HALOBETASOL PROPIONATEHALOBETASOL PROPIONATECREAM;TOPICAL0.05%NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0713-0640Halobetasol PropionateHalobetasol PropionateCosette Pharmaceuticals, Inc.ANDACurrent
0713-0640Halobetasol PropionateHalobetasol PropionateG&W Laboratories, Inc.ANDACurrent
0713-0640Halobetasol PropionateHalobetasol PropionateCosette Pharmaceuticals, Inc.ANDACurrent
0713-0640Halobetasol PropionateHalobetasol PropionateCosette Pharmaceuticals, Inc.ANDACurrent
42254-250Halobetasol PropionateHalobetasol PropionateRebel Distributors CorpANDACurrent