FDA.reportPublic FDA data

Application 020208

Type
NDA
Sponsor
BAUSCH

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020208-001METROGEL-VAGINALMETRONIDAZOLE0.75%GEL / VAGINALRLD1992-08-17

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N020208-001METROGEL-VAGINAL0.75%GEL / VAGINALRLD1992-08-17a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetronidazoleMETRONIDAZOLEA-S Medication Solutions8b2c294b-ed70-447c-bbc4-2a8b59f1aca42023-10-25Warnings, Adverse reactionsExact identifier
application applno (NDA): 020208
application number: NDA020208
ndc (product): 50090-2126

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

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