FDA.reportPublic FDA data

Application 012806

Type
NDA
Sponsor
ALMIRALL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CORDRANFLURANDRENOLIDEOINTMENT;TOPICAL0.05%YesYes
002CORDRAN SPFLURANDRENOLIDECREAM;TOPICAL0.05%YesYes
003CORDRAN SPFLURANDRENOLIDECREAM;TOPICAL0.025%YesYes
004CORDRANFLURANDRENOLIDEOINTMENT;TOPICAL0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16110-026CordranflurandrenolideAlmirall, LLCNDACurrent
16110-026CordranflurandrenolideAqua PharmaceuticalsNDACurrent
16110-026CordranflurandrenolideAlmirall, LLCNDACurrent
16110-034CordranflurandrenolideAlmirall, LLCNDACurrent
16110-034CordranflurandrenolideAqua PharmaceuticalsNDACurrent
16110-034CordranflurandrenolideAlmirall, LLCNDACurrent
16110-035CordranflurandrenolideAlmirall, LLCNDACurrent
16110-035CordranflurandrenolideAqua PharmaceuticalsNDACurrent
16110-035CordranflurandrenolideAlmirall, LLCNDACurrent
51672-5301FlurandrenolideFlurandrenolideTaro Pharmaceuticals U.S.A., Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10824SUPPL2013-07-30
343SUPPL2013-06-14
12037SUPPL2002-07-17