FDA.reportPublic FDA data

Application 207651

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDECREAM;TOPICAL0.025%NoNo
002TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDECREAM;TOPICAL0.1%NoNo
003TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDECREAM;TOPICAL0.5%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67877-470TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEAscend Laboratories, LLCANDACurrent
67877-470TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEAscend Laboratories, LLCANDACurrent
67877-471TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEAscend Laboratories, LLCANDACurrent
67877-471TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEAscend Laboratories, LLCANDACurrent
67877-472TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEAscend Laboratories, LLCANDACurrent
67877-472TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEAscend Laboratories, LLCANDACurrent