FDA.reportPublic FDA data

Application 076408

Type
ANDA
Sponsor
FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METRONIDAZOLEMETRONIDAZOLECREAM;TOPICAL0.75%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0168-0323MetronidazoleMetronidazoleE.FOUGERA & CO. A division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0323MetronidazoleMetronidazoleFougera Pharmaceuticals Inc.ANDACurrent
0168-0323MetronidazoleMetronidazoleFougera Pharmaceuticals Inc.ANDACurrent
0168-0323MetronidazoleMetronidazoleFougera Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43074ORIG2007-11-19
8906ORIG2004-06-01