Application 211027

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HALCINONIDEHALCINONIDECREAM;TOPICAL0.1%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-8056HalcinonideHalcinonideMylan Pharmaceuticals Inc.ANDACurrent
0378-8056HalcinonideHalcinonideMylan Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60139ORIG2019-09-27