FDA.reportPublic FDA data

Application 208724

Type
ANDA
Sponsor
TOLMAR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZELAIC ACIDAZELAIC ACIDGEL;TOPICAL15%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1624Azelaic AcidAzelaic AcidAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1624Azelaic AcidAzelaic AcidAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1624Azelaic AcidAzelaic AcidImpax GenericsANDACurrent
0115-1624Azelaic AcidAzelaic AcidAmneal Pharmaceuticals of New York LLCANDACurrent