FDA.reportPublic FDA data

Application 075733

Type
ANDA
Sponsor
NOVAST LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLOBETASOL PROPIONATE (EMOLLIENT)CLOBETASOL PROPIONATECREAM;TOPICAL0.05%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50742-311Clobetasol Propionate (Emollient)Clobetasol PropionateIngenus Pharmaceuticals, LLCANDACurrent
50742-311Clobetasol Propionate (Emollient)Clobetasol PropionateIngenus Pharmaceuticals, LLCANDACurrent
62559-980Clobetasol Propionate (Emmolient)Clobetasol PropionateANI Pharmaceuticals, Inc.ANDACurrent
62559-980Clobetasol Propionate (Emmolient)Clobetasol PropionateANI Pharmaceuticals, Inc.ANDACurrent
68071-2725Clobetasol Propionate (Emmolient)Clobetasol PropionateNuCare Pharmaceuticals,Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22497ORIG2003-12-24
18421ORIG2003-12-24
8779ORIG2003-12-24