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 42 .
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.
Product history page 1 of 2 · 42 observed 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 2026-08-18 06:07:40 2026-07 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205223-001 NUVESSA 1.3% GEL / VAGINAL AB RLD, RS 2014-03-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205223-001 NUVESSA 1.3% GEL / VAGINAL AB RLD, RS 2014-03-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205223-001 NUVESSA 1.3% GEL / VAGINAL AB RLD, RS 2014-03-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205223-001 NUVESSA 1.3% GEL / VAGINAL AB RLD, RS 2014-03-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205223-001 NUVESSA 1.3% GEL / VAGINAL AB RLD, RS 2014-03-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205223-001 NUVESSA 1.3% GEL / VAGINAL AB RLD, RS 2014-03-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205223-001 NUVESSA 1.3% GEL / VAGINAL AB RLD, RS 2014-03-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205223-001 NUVESSA 1.3% GEL / VAGINAL AB RLD, RS 2014-03-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205223-001 NUVESSA 1.3% GEL / VAGINAL AB RLD, RS 2014-03-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 e64feba35796…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 8 · 290 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N205223-001 8877792 2028-02-02 Drug product 2015-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205223-001 7893097 2028-02-19 Drug product 2015-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205223-001 8658678 2028-06-27 U-1682 2015-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205223-001 10238634 2032-06-28 Drug product 2019-04-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205223-001 10596155 2032-06-28 Drug product 2020-04-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205223-001 8946276 2032-06-28 U-1664 2015-03-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205223-001 9198858 2032-06-28 U-1664 2015-12-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205223-001 8877792 2028-02-02 Drug product 2015-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205223-001 7893097 2028-02-19 Drug product 2015-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205223-001 8658678 2028-06-27 U-1682 2015-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205223-001 10238634 2032-06-28 Drug product 2019-04-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205223-001 10596155 2032-06-28 Drug product 2020-04-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205223-001 8946276 2032-06-28 U-1664 2015-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205223-001 9198858 2032-06-28 U-1664 2015-12-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205223-001 8877792 2028-02-02 Drug product 2015-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205223-001 7893097 2028-02-19 Drug product 2015-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205223-001 8658678 2028-06-27 U-1682 2015-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205223-001 10238634 2032-06-28 Drug product 2019-04-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205223-001 10596155 2032-06-28 Drug product 2020-04-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205223-001 8946276 2032-06-28 U-1664 2015-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205223-001 9198858 2032-06-28 U-1664 2015-12-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205223-001 8877792 2028-02-02 Drug product 2015-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205223-001 7893097 2028-02-19 Drug product 2015-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205223-001 8658678 2028-06-27 U-1682 2015-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205223-001 10238634 2032-06-28 Drug product 2019-04-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205223-001 10596155 2032-06-28 Drug product 2020-04-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205223-001 8946276 2032-06-28 U-1664 2015-03-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205223-001 9198858 2032-06-28 U-1664 2015-12-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205223-001 8877792 2028-02-02 Drug product 2015-04-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205223-001 7893097 2028-02-19 Drug product 2015-04-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205223-001 8658678 2028-06-27 U-1682 2015-04-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205223-001 10238634 2032-06-28 Drug product 2019-04-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205223-001 10596155 2032-06-28 Drug product 2020-04-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205223-001 8946276 2032-06-28 U-1664 2015-03-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205223-001 9198858 2032-06-28 U-1664 2015-12-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205223-001 8877792 2028-02-02 Drug product 2015-04-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205223-001 7893097 2028-02-19 Drug product 2015-04-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205223-001 8658678 2028-06-27 U-1682 2015-04-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205223-001 10238634 2032-06-28 Drug product 2019-04-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205223-001 10596155 2032-06-28 Drug product 2020-04-07 b8a1b40f171c…
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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