FDA.reportPublic FDA data

Application 086195

Type
ANDA
Sponsor
MYLAN SPECIALITY LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROCTOFOAM HCHYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDEAEROSOL, METERED;TOPICAL1%;1%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0037-6822PROCTOFOAMpramoxine hydrochloride hydrocortisone acetateMeda PharmaceuticalsANDACurrent
0037-6822PROCTOFOAMpramoxine hydrochloride hydrocortisone acetateMeda PharmaceuticalsANDACurrent
0037-6822PROCTOFOAMpramoxine hydrochloride hydrocortisone acetateMeda Pharmaceuticals Inc.ANDACurrent
21695-982Proctofoamhydrocortisone acetate and pramoxine hydrochlorideRebel Distributors CorpANDACurrent