FDA.reportPublic FDA data

Application 020531

Type
NDA
Sponsor
GALDERMA LABS LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METROCREAMMETRONIDAZOLECREAM;TOPICAL0.75%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0299-3836MetroCreammetronidazoleGalderma Laboratories, L.P.NDACurrent
66993-960METRONIDAZOLEMETRONIDAZOLEPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
69007-836METRONIDAZOLEMETRONIDAZOLEOwen LaboratoriesNDA AUTHORIZED GENERICCurrent
72189-306Metronidazole Topical CreamMetronidazole Topical CreamDirectRxNDA AUTHORIZED GENERICCurrent
72189-306Metronidazole Topical CreamMetronidazole Topical CreamDirectRxNDA AUTHORIZED GENERICCurrent