Application 013790

Type
NDA
Sponsor
ALMIRALL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CORDRANFLURANDRENOLIDELOTION;TOPICAL0.05%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16110-052CordranflurandrenolideAlmirall, LLCNDACurrent
16110-052CordranflurandrenolideAqua PharmaceuticalsNDACurrent
16110-052CordranflurandrenolideAlmirall, LLCNDACurrent
51672-5298FlurandrenolideFlurandrenolideTaro Pharmaceuticals U.S.A., Inc.NDACurrent
51672-5298FlurandrenolideFlurandrenolideTaro Pharmaceuticals U.S.A., Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
12057SUPPL2011-07-29
33111SUPPL2011-07-28
12056SUPPL2003-11-25