FDA.reportPublic FDA data

Application 021056

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TARGRETINBEXAROTENEGEL;TOPICAL1%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-5525TargretinbexaroteneValeant Pharmaceuticals North America LLCNDACurrent
0187-5525TargretinbexaroteneBausch Health US, LLCNDACurrent
0187-5525TargretinbexaroteneValeant Pharmaceuticals North America LLCNDACurrent
0187-5525TargretinbexaroteneBausch Health US, LLCNDACurrent
0187-5525TargretinbexaroteneBausch Health US, LLCNDACurrent
68682-002bexarotenebexaroteneOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-002bexarotenebexaroteneOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-002bexarotenebexaroteneOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
4177SUPPL2011-04-13
14256SUPPL2011-04-11
21398ORIG2001-07-12
35990ORIG2000-06-28
4176ORIG2000-06-28