FDA.reportPublic FDA data

Application 074222

Type
ANDA
Sponsor
HI TECH PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EMBELINECLOBETASOL PROPIONATESOLUTION;TOPICAL0.05%NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4630Clobetasol PropionateClobetasol PropionateA-S Medication SolutionsANDACurrent
50090-4630Clobetasol PropionateClobetasol PropionateA-S Medication SolutionsANDACurrent
50383-266Clobetasol PropionateClobetasol PropionateAkornANDACurrent
50383-266Clobetasol PropionateClobetasol PropionateHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-266Clobetasol PropionateClobetasol PropionateHi-Tech Pharmacal Co., Inc.ANDACurrent
70030-166Clobetasol PropionateClobetasol PropionateHyGen Pharmaceuticals, Inc.ANDACurrent