FDA.reportPublic FDA data

Application 021108

Type
NDA
Sponsor
VALEANT PHARMS NORTH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RENOVATRETINOINCREAM;TOPICAL0.02%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-5150RenovaTretinoinValeant Pharmaceuticals North America LLCNDACurrent
0187-5150RenovaTretinoinBausch Health US LLCNDACurrent
0187-5150RenovaTretinoinBausch Health Americas Inc.NDACurrent
0187-5150RenovaTretinoinBausch Health US LLCNDACurrent
0187-5150RenovaTretinoinBausch Health US LLCNDACurrent
42254-165RenovaTretinoinRebel Distributors CorpNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
36123SUPPL2014-06-17
4344SUPPL2014-06-17
14396SUPPL2004-06-15
41954ORIG2004-03-28
4343SUPPL2002-07-14
14395ORIG2000-08-31
4342ORIG2000-08-31