FDA.reportPublic FDA data

Application 211688

Type
ANDA
Sponsor
ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TACROLIMUSTACROLIMUSOINTMENT;TOPICAL0.03%NoNo
002TACROLIMUSTACROLIMUSOINTMENT;TOPICAL0.1%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16729-421TacrolimusTacrolimusAccord Healthcare Inc.ANDACurrent
16729-421TacrolimusTacrolimusAccord Healthcare Inc.ANDACurrent
16729-421TacrolimusTacrolimusAccord Healthcare Inc.ANDACurrent
16729-422TacrolimusTacrolimusAccord Healthcare Inc.ANDACurrent
16729-422TacrolimusTacrolimusAccord Healthcare Inc.ANDACurrent
16729-422TacrolimusTacrolimusAccord Healthcare Inc.ANDACurrent