FDA.reportPublic FDA data

Application 078178

Type
ANDA
Sponsor
ACP NIMBLE

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0713-0637MetronidazoleMetronidazoleCosette Pharmaceuticals, Inc.ANDACurrent
0713-0637MetronidazoleMetronidazoleCosette Pharmaceuticals, Inc.ANDACurrent
0713-0637MetronidazoleMetronidazoleG&W Laboratories, Inc.ANDACurrent
0713-0637MetronidazoleMetronidazoleCosette Pharmaceuticals, Inc.ANDACurrent
0713-0637MetronidazoleMetronidazoleCosette Pharmaceuticals, Inc.ANDACurrent
43538-182RosadanmetronidazoleMedimetriks Pharmaceuticals, Inc.ANDACurrent
43538-182RosadanmetronidazoleMedimetriks Pharmaceuticals, Inc.ANDACurrent
43538-183RosadanmetronidazoleMedimetriks Pharmaceuticals, Inc.ANDACurrent
43538-183RosadanmetronidazoleMedimetriks Pharmaceuticals, Inc.ANDACurrent