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 | REMEDYREPACK INC. | 5cc3fd98-d579-432e-a4b5-b6d5586991a6 | 2026-08-05 | Boxed warning, Warnings, Adverse reactions | Metronidazole METRONIDAZOLE |
| Metronidazole | METRONIDAZOLE | REMEDYREPACK INC. | dc28753c-95ec-4b41-ad77-c4a66698d9db | 2026-08-04 | Boxed warning, Warnings, Adverse reactions | Metronidazole METRONIDAZOLE |
| metronidazole | METRONIDAZOLE | REMEDYREPACK INC. | b49a8ad0-2cf9-4386-8bf5-1b1df87b0022 | 2026-08-03 | Boxed warning, Warnings, Adverse reactions | metronidazole METRONIDAZOLE |
| metronidazole | METRONIDAZOLE | REMEDYREPACK INC. | d5784eeb-6b99-4e8a-847b-b0d1090ed48a | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | metronidazole METRONIDAZOLE |
| Metronidazole | METRONIDAZOLE | REMEDYREPACK INC. | 2f7d84d4-1085-4243-be88-442eecb85205 | 2026-07-22 | Boxed warning, Warnings, Adverse reactions | Metronidazole METRONIDAZOLE |
| Vagizole | METRONIDAZOLE | iNutrition LLC | fd5e884b-cf07-493b-bb93-039bbb0c4784 | 2026-07-22 | Warnings, Adverse reactions | METRONIDAZOLE |
| Metronidazole | METRONIDAZOLE | Bryant Ranch Prepack | 5cf3cc1f-601e-4997-bfb2-a573c31c8189 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | Metronidazole METRONIDAZOLE |
| Metronidazole | METRONIDAZOLE | Sun Pharmaceutical Industries, Inc. | 4a233572-2471-4e99-a45e-2de978abcf16 | 2026-07-15 | Adverse reactions | Metronidazole METRONIDAZOLE |
| Metronidazole | METRONIDAZOLE | Sun Pharmaceutical Industries, Inc. | 5a504f74-bccd-433a-bd5b-6822f98c34df | 2026-07-15 | Warnings, Adverse reactions | Metronidazole METRONIDAZOLE |
| Metronidazole | METRONIDAZOLE | Sun Pharmaceutical Industries, Inc. | 5842a554-58d1-4ee4-99aa-1e6029a69be2 | 2026-07-15 | Warnings, Adverse reactions | Metronidazole METRONIDAZOLE |
| Metronidazole | METRONIDAZOLE | Bryant Ranch Prepack | 4748ba37-9d66-497d-aa9f-ca2d541c5f41 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | Metronidazole METRONIDAZOLE |
| Metronidazole | METRONIDAZOLE | Preferred Pharmaceuticals Inc. | 59e53582-244a-4e9d-b18e-75dddc6a5052 | 2026-07-08 | Adverse reactions | Metronidazole METRONIDAZOLE |
| Metronidazole | METRONIDAZOLE | REMEDYREPACK INC. | cfeab9e3-58b9-4890-9185-11b62904e2af | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | Metronidazole METRONIDAZOLE |
| Metronidazole | METRONIDAZOLE | Preferred Pharmaceuticals Inc. | cbee69e8-029c-49d2-89cd-f504b8e0ac28 | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | Metronidazole METRONIDAZOLE |
| Metronidazole | METRONIDAZOLE | Preferred Pharmaceuticals Inc. | 3e0a14f1-961b-4722-bfea-aafcc5d7706c | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | Metronidazole METRONIDAZOLE |
| Metronidazole | METRONIDAZOLE | REMEDYREPACK INC. | 53918705-d2fe-4c6b-9501-a619a8ad3991 | 2026-07-03 | Boxed warning, Warnings, Adverse reactions | Metronidazole METRONIDAZOLE |
| Metronidazole | METRONIDAZOLE | Kanchan Healthcare Inc | 8836334e-6db4-44be-bc9e-099b26322cf4 | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | Metronidazole METRONIDAZOLE |
| metronidazole | METRONIDAZOLE | Bryant Ranch Prepack | 99886f54-4ebe-4a2d-b779-bcfbb0634db1 | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | metronidazole METRONIDAZOLE |
| Metronidazole | METRONIDAZOLE | REMEDYREPACK INC. | 49bed450-7fa8-401c-8c8c-afc1c61d473a | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | Metronidazole METRONIDAZOLE |
| Metronidazole | METRONIDAZOLE | REMEDYREPACK INC. | 3c0ebb00-a0ae-4f64-9bfc-de01193191e8 | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | Metronidazole METRONIDAZOLE |