FDA.reportPublic FDA data

Application 021152

Type
NDA
Sponsor
FOUGERA PHARMS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0168-0434FLUTICASONE PROPIONATEfluticasone propionateE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0168-0434FLUTICASONE PROPIONATEfluticasone propionateFougera Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
10337-434Cutivatefluticasone propionatePharmaDerm a division of Fougera Pharmaceuticals Inc.NDACurrent
10337-434Cutivatefluticasone propionatePharmaDerm a division of Fougera Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
14511SUPPL2015-01-20
4479SUPPL2015-01-20
36221SUPPL2011-05-16
4480SUPPL2011-05-16
4478SUPPL2010-09-08
14510SUPPL2010-09-07
21479ORIG2007-09-10
26913ORIG2005-04-06
63518ORIG1900-01-01
63010SUPPL1900-01-01
51116SUPPL1900-01-01
51115SUPPL1900-01-01
51113SUPPL1900-01-01