Home Applications 205223 Application 205223
Type NDA
Sponsor CHEMO RESEARCH SL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NUVESSA METRONIDAZOLE GEL;VAGINAL 1.3% Yes Yes
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 N205223-001 NUVESSA METRONIDAZOLE 1.3% GEL / VAGINAL RLD, RS 2014-03-24
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205223-001 8877792 2028-02-02 Drug product 2015-04-29 N205223-001 7893097 2028-02-19 Drug product 2015-04-29 N205223-001 8658678 2028-06-27 U-1682 2015-04-29 N205223-001 10238634 2032-06-28 Drug product 2019-04-25 N205223-001 10596155 2032-06-28 Drug product 2020-04-07 N205223-001 8946276 2032-06-28 U-1664 2015-03-04 N205223-001 9198858 2032-06-28 U-1664 2015-12-15
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 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N205223-001 8877792 2028-02-02 Drug product 2015-04-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N205223-001 7893097 2028-02-19 Drug product 2015-04-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N205223-001 8658678 2028-06-27 U-1682 2015-04-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N205223-001 10238634 2032-06-28 Drug product 2019-04-25 a50c72e98297…2026-08-01 22:54:32 2026-06 N205223-001 10596155 2032-06-28 Drug product 2020-04-07 a50c72e98297…2026-08-01 22:54:32 2026-06 N205223-001 8946276 2032-06-28 U-1664 2015-03-04 a50c72e98297…2026-08-01 22:54:32 2026-06 N205223-001 9198858 2032-06-28 U-1664 2015-12-15 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 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0642-7466 Nuvessa metronidazole Exeltis USA, Inc. NDA Current 0642-7466 Nuvessa metronidazole Exeltis USA, Inc. NDA Current 0642-7466 Nuvessa metronidazole Exeltis USA, Inc. NDA Current 0642-7466 Nuvessa metronidazole Exeltis USA, Inc. NDA Current 0642-7466 Nuvessa metronidazole Exeltis USA, Inc. NDA Current 0642-7466 Nuvessa metronidazole Exeltis USA, Inc. NDA Current 0642-7466 Nuvessa metronidazole Exeltis USA, Inc. NDA Current