Home Applications 021789 Application 021789
Type NDA
Sponsor GALDERMA LABS LP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 METROGEL METRONIDAZOLE GEL;TOPICAL 1% 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 N021789-001 METROGEL METRONIDAZOLE 1% GEL / TOPICAL AB RLD, RS 2005-06-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021789-001 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.
Product history page 1 of 2 · 41 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 2026-02-19 14:30 UTC 2026-02 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021789-001 6881726 2022-02-21 U-743 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021789-001 7348317 2022-02-21 U-743 Drug product 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021789-001 6881726 2022-02-21 U-743 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021789-001 7348317 2022-02-21 U-743 Drug product 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021789-001 6881726 2022-02-21 U-743 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021789-001 7348317 2022-02-21 U-743 Drug product 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021789-001 6881726 2022-02-21 U-743 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021789-001 7348317 2022-02-21 U-743 Drug product 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021789-001 6881726 2022-02-21 U-743 Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021789-001 7348317 2022-02-21 U-743 Drug product bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021789-001 6881726 2022-02-21 U-743 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021789-001 7348317 2022-02-21 U-743 Drug product 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021789-001 6881726 2022-02-21 U-743 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021789-001 7348317 2022-02-21 U-743 Drug product 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021789-001 6881726 2022-02-21 U-743 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021789-001 7348317 2022-02-21 U-743 Drug product 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021789-001 6881726 2022-02-21 U-743 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021789-001 7348317 2022-02-21 U-743 Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021789-001 6881726 2022-02-21 U-743 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021789-001 7348317 2022-02-21 U-743 Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021789-001 6881726 2022-02-21 U-743 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021789-001 7348317 2022-02-21 U-743 Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021789-001 6881726 2022-02-21 U-743 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021789-001 7348317 2022-02-21 U-743 Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021789-001 6881726 2022-02-21 U-743 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021789-001 7348317 2022-02-21 U-743 Drug product ea99ee380514…2023-01-26 05:58 UTC 2023-01 N021789-001 6881726 2022-02-21 U-743 Drug product 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N021789-001 7348317 2022-02-21 U-743 Drug product 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021789-001 6881726 2022-02-21 U-743 Drug product 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021789-001 7348317 2022-02-21 U-743 Drug product 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021789-001 6881726 2022-02-21 U-743 Drug product f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N021789-001 7348317 2022-02-21 U-743 Drug product f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021789-001 6881726 2022-02-21 U-743 Drug product e64feba35796…2022-09-29 23:25 UTC 2022-09 N021789-001 7348317 2022-02-21 U-743 Drug product e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021789-001 6881726 2022-02-21 U-743 Drug product cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021789-001 7348317 2022-02-21 U-743 Drug product cb3db0bc1861…
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 0299-3820 METROGEL metronidazole Galderma Laboratories, L.P. NDA Current 0299-3820 METROGEL metronidazole Galderma Laboratories, L.P. NDA Current 0299-3820 METROGEL metronidazole Galderma Laboratories, L.P. NDA Current 0299-3820 METROGEL metronidazole Galderma Laboratories, L.P. NDA Current 51672-5295 metronidazole metronidazole Taro Pharmaceuticals U.S.A., Inc. NDA AUTHORIZED GENERIC Current 66993-936 metronidazole metronidazole Prasco Laboratories NDA AUTHORIZED GENERIC Current 66993-936 metronidazole metronidazole Prasco Laboratories NDA AUTHORIZED GENERIC Current