FDA.reportPublic FDA data

Application 204286

Type
NDA
Sponsor
SEBELA IRELAND LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NAFTINNAFTIFINE HYDROCHLORIDEGEL;TOPICAL2%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
54766-772NaftinNaftifine HydrochlorideSebela Pharmaceuticals Inc.NDACurrent
54766-772NaftinNaftifine HydrochlorideSebela Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62578SUPPL2020-04-15
62528SUPPL2020-04-10
53992SUPPL2018-05-03
53983SUPPL2018-05-02
19541SUPPL2014-10-15
32538SUPPL2014-10-14
32539SUPPL2014-09-25
43460ORIG2013-10-03
24464ORIG2013-10-03
40371ORIG2013-07-11
32537ORIG2013-07-01
51445ORIG1900-01-01
51444ORIG1900-01-01