Application 076519
- Type
- ANDA
- Sponsor
- ABLE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METRONIDAZOLE | METRONIDAZOLE | TABLET;ORAL | 250MG | No | No |
| 002 | METRONIDAZOLE | METRONIDAZOLE | TABLET;ORAL | 500MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076519-001 | METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET / ORAL | 2003-06-27 | ||
| A076519-002 | METRONIDAZOLE | METRONIDAZOLE | 500MG | TABLET / ORAL | 2003-06-27 |
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 | 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 | A076519-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | 2003-06-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076519-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | 2003-06-27 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076519-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | 2003-06-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076519-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | 2003-06-27 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076519-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | 2003-06-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076519-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | 2003-06-27 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076519-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | 2003-06-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076519-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | 2003-06-27 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076519-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | 2003-06-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076519-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | 2003-06-27 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076519-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | 2003-06-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076519-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | 2003-06-27 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076519-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | 2003-06-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076519-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | 2003-06-27 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076519-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | 2003-06-27 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076519-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | 2003-06-27 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076519-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | 2003-06-27 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076519-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | 2003-06-27 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076519-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | 2003-06-27 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076519-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | 2003-06-27 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076519-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | 2003-06-27 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076519-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | 2003-06-27 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076519-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | 2003-06-27 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076519-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | 2003-06-27 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076519-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | 2003-06-27 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076519-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | 2003-06-27 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076519-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | 2003-06-27 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076519-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | 2003-06-27 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076519-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | 2003-06-27 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076519-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | 2003-06-27 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076519-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | 2003-06-27 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076519-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | 2003-06-27 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076519-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | 2003-06-27 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076519-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | 2003-06-27 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076519-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | 2003-06-27 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076519-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | 2003-06-27 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076519-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | 2003-06-27 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076519-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | 2003-06-27 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076519-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | 2003-06-27 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076519-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | 2003-06-27 | 782e0a99824c… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Metronidazole | METRONIDAZOLE | Coupler LLC | 545f2900-745c-c33c-e063-6294a90a5e4f | 2026-06-16 | Boxed warning, Warnings, Adverse reactions | Metronidazole METRONIDAZOLE |
| Metronidazole | METRONIDAZOLE | Cardinal Health 107, LLC | 4e1ac737-c353-4764-bd35-dc844e75b562 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | Metronidazole METRONIDAZOLE |
| METRONIDAZOLE | METRONIDAZOLE | Sun Pharmaceutical Industries, Inc. | 7187779a-1f4c-4607-af53-4119e324aad5 | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | METRONIDAZOLE METRONIDAZOLE |
| Flagyl | METRONIDAZOLE | Pfizer Laboratories Div Pfizer Inc | a2883ca1-5a9a-4259-9d80-46ab67274384 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | METRONIDAZOLE |
| Metronidazole | METRONIDAZOLE | Gland Pharma Limited | 74cf111a-9b83-4f93-b0e8-bc252d471d43 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | Metronidazole METRONIDAZOLE |
| Metronidazole | METRONIDAZOLE | WG Critical Care, LLC | e4ea0c09-cdd1-4708-962c-6ba28b989df3 | 2026-05-12 | Boxed warning, Warnings, Adverse reactions | Metronidazole METRONIDAZOLE |
| metronidazole | METRONIDAZOLE | Method Pharmaceuticals LLC | 2ae49bf4-a23b-bdcc-e063-6294a90a80a9 | 2026-05-04 | Boxed warning, Warnings, Adverse reactions | metronidazole METRONIDAZOLE |
| metronidazole | METRONIDAZOLE | ST. MARY'S MEDICAL PARK PHARMACY | e3a32908-9db1-6ca7-e053-2a95a90a82fb | 2026-05-01 | Boxed warning, Warnings, Adverse reactions | metronidazole METRONIDAZOLE |
| Metronidazole | METRONIDAZOLE | Coupler LLC | 509c8d03-e199-8154-e063-6394a90afddc | 2026-04-29 | Boxed warning, Warnings, Adverse reactions | Metronidazole METRONIDAZOLE |
| METRONIDAZOLE | METRONIDAZOLE | B. Braun Medical Inc. | fd191c06-9d3b-4e46-9f79-90f6af614947 | 2026-04-23 | Boxed warning, Warnings, Adverse reactions | METRONIDAZOLE METRONIDAZOLE |
| Metronidazole | METRONIDAZOLE | Northstar Rx LLC | 65cda174-d840-488a-96d0-74d6086b7048 | 2026-04-17 | Warnings, Adverse reactions | Metronidazole METRONIDAZOLE |
| Metronidazole | METRONIDAZOLE | St. Mary's Medical Park Pharmacy | 60689b96-cb58-925a-e053-2a91aa0a32a3 | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | Metronidazole METRONIDAZOLE |
| Metronidazole | METRONIDAZOLE | Bryant Ranch Prepack | 1277591d-ccf4-428a-b647-cb1ef3fbf561 | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | Metronidazole METRONIDAZOLE |
| Metronidazole | METRONIDAZOLE | A-S Medication Solutions | 02046a22-a5eb-4bb7-bec7-e5a2aa55e142 | 2026-03-18 | Boxed warning, Warnings, Adverse reactions | Metronidazole METRONIDAZOLE |
| Metronidazole | METRONIDAZOLE | NuCare Pharmaceuticals,Inc. | c225a455-ec25-2213-e053-2995a90a3389 | 2026-03-13 | Boxed warning, Warnings, Adverse reactions | Metronidazole METRONIDAZOLE |
| Metronidazole | METRONIDAZOLE | REMEDYREPACK INC. | ca450fad-0513-4c45-8ea0-1f46bcbf6a36 | 2026-03-12 | Boxed warning, Warnings, Adverse reactions | Metronidazole METRONIDAZOLE |
| Metronidazole | METRONIDAZOLE | BluePoint Laboratories | 3cf021b6-5794-4a86-b09d-bece0ba8b302 | 2026-02-23 | Boxed warning, Warnings, Adverse reactions | Metronidazole METRONIDAZOLE |
| Metronidazole | METRONIDAZOLE | Viona Pharmaceuticals Inc | 40a8c59b-a46d-4e5b-bd38-330cdbc1022c | 2026-02-19 | Adverse reactions | Metronidazole METRONIDAZOLE |
| Metronidazole | METRONIDAZOLE | Zydus Lifesciences Limited | aa7fc40e-64a1-4155-bb39-77ed7b7f2e67 | 2026-02-19 | Metronidazole METRONIDAZOLE | |
| metronidazole vaginal | METRONIDAZOLE | REMEDYREPACK INC. | b8fbd105-90ae-4af4-9313-61834aaf4a2c | 2026-02-13 | Warnings, Adverse reactions | METRONIDAZOLE |