FDA.reportPublic FDA data

Application 020743

Type
NDA
Sponsor
VALEANT PHARMS NORTH

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-5202NoritatemetronidazoleBausch Health US, LLCNDACurrent
0187-5202NoritatemetronidazoleValeant Pharmaceuticals North America LLCNDACurrent
0187-5202NoritatemetronidazoleBausch Health US, LLCNDACurrent
0187-5202NoritatemetronidazoleBausch Health US, LLCNDACurrent
0187-5202NoritatemetronidazoleBausch Health US, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
3248SUPPL2004-07-06
41638ORIG2003-08-07
3247SUPPL2003-04-18
13329SUPPL2003-04-04