FDA.reportPublic FDA data

Application 085368

Type
ANDA
Sponsor
SEBELA IRELAND LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRAMOSONEHYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDECREAM;TOPICAL1%;1%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45802-144hydrocortisone acetate pramoxine hclhydrocortisone acetate pramoxine hclPadagis Israel Pharmaceuticals LtdANDACurrent
45802-144hydrocortisone acetate pramoxine hclhydrocortisone acetate pramoxine hclPerrigo New York IncANDACurrent
54766-716Pramosone Creamhydrocortisone acetate and pramoxine hydrochlorideSebela Pharmaceuticals Inc.ANDACurrent
54766-778Analpram HChydrocortisone acetate and pramoxine hydrochlorideSebela Pharmaceuticals Inc.ANDACurrent
63629-8669hydrocortisone acetate pramoxine hclhydrocortisone acetate pramoxine hclBryant Ranch PrepackANDACurrent
63629-8669hydrocortisone acetate pramoxine hclhydrocortisone acetate pramoxine hclBryant Ranch PrepackANDACurrent
63629-8669hydrocortisone acetate pramoxine hclhydrocortisone acetate pramoxine hclBryant Ranch PrepackANDACurrent