FDA.reportPublic FDA data

Application 076931

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUPRENORPHINE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 0.3MG BASE/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9246Buprenorphine HydrochlorideBuprenorphine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9246Buprenorphine HydrochlorideBuprenorphine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9246Buprenorphine HydrochlorideBuprenorphine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent