Home Applications 020208 Application 020208
Type NDA
Sponsor BAUSCH Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 METROGEL-VAGINAL METRONIDAZOLE GEL;VAGINAL 0.75% 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 N020208-001 METROGEL-VAGINAL METRONIDAZOLE 0.75% GEL / VAGINAL RLD 1992-08-17
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.
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 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL RLD 1992-08-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL RLD 1992-08-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL RLD 1992-08-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL AB RLD, RS 1992-08-17 e64feba35796…
Observed Orange Book normalized TE history# 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 · 11 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 33261-786 Metronidazole metronidazole Aidarex Pharmaceuticals LLC NDA AUTHORIZED GENERIC Current 50090-2126 Metronidazole metronidazole A-S Medication Solutions NDA AUTHORIZED GENERIC Current 50090-2126 Metronidazole metronidazole A-S Medication Solutions NDA AUTHORIZED GENERIC Current 68071-1753 Metronidazole metronidazole NuCare Pharmaceuticals,Inc. NDA AUTHORIZED GENERIC Current 68071-1753 Metronidazole metronidazole NuCare Pharmaceuticals,Inc. NDA AUTHORIZED GENERIC Current 68682-455 Metronidazole metronidazole Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-455 Metronidazole metronidazole Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-455 Metronidazole metronidazole Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-455 Metronidazole metronidazole Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-455 Metronidazole metronidazole Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 99207-130 MetroGel-Vaginal metronidazole Medicis Pharmaceutical Corp NDA Current