Home Applications 077197 Application 077197
Type ANDA
Sponsor FOUGERA PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 METRONIDAZOLE METRONIDAZOLE LOTION;TOPICAL 0.75% No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077197-001 METRONIDAZOLE METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077197-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A077197-001 AB 1 a50c72e98297…
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0168-0383 Metronidazole Metronidazole Fougera Pharmaceuticals Inc. ANDA Current 0168-0383 Metronidazole Metronidazole Fougera Pharmaceuticals Inc. ANDA Current 0168-0383 Metronidazole Metronidazole E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 9017 ORIG 2006-05-25