FDA.reportPublic FDA data

Application 020208

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METROGEL-VAGINALMETRONIDAZOLEGEL;VAGINAL0.75%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
33261-786MetronidazolemetronidazoleAidarex Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
50090-2126MetronidazolemetronidazoleA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-2126MetronidazolemetronidazoleA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
68071-1753MetronidazolemetronidazoleNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
68071-1753MetronidazolemetronidazoleNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
68682-455MetronidazolemetronidazoleOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-455MetronidazolemetronidazoleOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-455MetronidazolemetronidazoleOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-455MetronidazolemetronidazoleOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-455MetronidazolemetronidazoleOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
99207-130MetroGel-VaginalmetronidazoleMedicis Pharmaceutical CorpNDACurrent