Application 206560
- Type
- ANDA
- Sponsor
- CADILA
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 |
|---|---|---|---|---|---|---|---|
| A206560-001 | METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2016-11-16 | |
| A206560-002 | METRONIDAZOLE | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2016-11-16 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A206560-001 | AB |
| A206560-002 | 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.
| 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 | A206560-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2016-11-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A206560-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2016-11-16 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206560-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2016-11-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206560-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2016-11-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206560-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2016-11-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206560-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2016-11-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206560-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2016-11-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206560-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2016-11-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206560-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2016-11-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206560-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2016-11-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206560-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2016-11-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206560-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2016-11-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206560-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2016-11-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206560-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2016-11-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206560-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2016-11-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206560-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2016-11-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206560-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2016-11-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206560-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2016-11-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206560-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2016-11-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206560-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2016-11-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A206560-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2016-11-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A206560-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2016-11-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206560-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2016-11-16 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206560-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2016-11-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206560-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2016-11-16 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206560-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2016-11-16 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206560-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2016-11-16 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206560-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2016-11-16 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A206560-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2016-11-16 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A206560-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2016-11-16 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206560-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2016-11-16 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206560-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2016-11-16 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A206560-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2016-11-16 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A206560-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2016-11-16 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A206560-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2016-11-16 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A206560-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2016-11-16 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A206560-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2016-11-16 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A206560-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2016-11-16 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A206560-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2016-11-16 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A206560-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2016-11-16 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A206560-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A206560-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A206560-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206560-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206560-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206560-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A206560-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206560-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206560-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206560-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206560-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206560-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206560-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206560-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206560-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206560-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206560-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206560-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206560-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206560-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A206560-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A206560-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206560-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206560-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206560-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206560-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206560-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206560-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A206560-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A206560-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206560-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206560-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A206560-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A206560-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A206560-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A206560-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A206560-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A206560-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A206560-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A206560-002 | AB | 1 | bb7c543d1eb4… |
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. | b49a8ad0-2cf9-4386-8bf5-1b1df87b0022 | 2026-08-03 | Boxed warning, Warnings, Adverse reactions | 206560 ANDA206560 70518-3042 |
| metronidazole | METRONIDAZOLE | REMEDYREPACK INC. | d5784eeb-6b99-4e8a-847b-b0d1090ed48a | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 206560 ANDA206560 70518-2663 |
| metronidazole | METRONIDAZOLE | ST. MARY'S MEDICAL PARK PHARMACY | e3a32908-9db1-6ca7-e053-2a95a90a82fb | 2026-05-01 | Boxed warning, Warnings, Adverse reactions | 206560 ANDA206560 60760-539 |
| metronidazole | METRONIDAZOLE | Sportpharm LLC | dc8e448e-ac4e-4efc-8851-c368e31b9d69 | 2026-02-05 | Boxed warning, Warnings, Adverse reactions | 206560 ANDA206560 |
| metronidazole | METRONIDAZOLE | Preferred Pharmaceuticals Inc. | ab695a3e-1721-491a-97a2-c3f617a8d9fc | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | 206560 ANDA206560 68788-7815 |
| metronidazole | METRONIDAZOLE | Northwind Health Company, LLC | 06bd4afb-4a45-294c-e063-6394a90a7ab1 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 206560 ANDA206560 |
| metronidazole | METRONIDAZOLE | PD-Rx Pharmaceuticals, Inc. | 8f1de4ca-a005-4ca9-a43a-380429c80d6f | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | 206560 ANDA206560 72789-195 |
| metronidazole | METRONIDAZOLE | Bryant Ranch Prepack | 356579f3-a9ed-49cf-bc0d-47b58a58cf85 | 2025-09-12 | Boxed warning, Warnings, Adverse reactions | 206560 ANDA206560 |
| metronidazole | METRONIDAZOLE | Viona Pharmaceuticals Inc | 0f108035-d2ab-49c1-9f8d-daae11f0efe0 | 2024-08-13 | Boxed warning, Warnings, Adverse reactions | 206560 ANDA206560 72578-008 72578-007 |
| METRONIDAZOLE | METRONIDAZOLE | Zydus Lifesciences Limited | f3ef765c-b531-4aaa-a86d-e32b7254ca48 | 2024-08-13 | Boxed warning, Warnings, Adverse reactions | 206560 ANDA206560 70771-1046 70771-1045 |
| metronidazole | METRONIDAZOLE | Bryant Ranch Prepack | 9e702861-87f5-4bc0-864d-317050020194 | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | 206560 ANDA206560 71335-1703 |
| metronidazole | METRONIDAZOLE | Bryant Ranch Prepack | 1030e723-cde9-44a7-8dab-2f0932ffcc2c | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | 206560 ANDA206560 71335-1775 |
| metronidazole | METRONIDAZOLE | Asclemed USA, Inc. | 89970965-a995-4ae4-a70b-bd2de38081e1 | 2024-04-26 | Boxed warning, Warnings, Adverse reactions | 206560 ANDA206560 |
| metronidazole | METRONIDAZOLE | NuCare Pharmaceuticals,Inc. | c2dbfec8-da5b-cd2b-e053-2a95a90ad17c | 2024-02-09 | Boxed warning, Warnings, Adverse reactions | 206560 ANDA206560 68071-2409 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-5247 | metronidazole | metronidazole | A-S Medication Solutions | ANDA | Current |
| 50090-5247 | metronidazole | metronidazole | A-S Medication Solutions | ANDA | Current |
| 50090-5247 | metronidazole | metronidazole | A-S Medication Solutions | ANDA | Current |
| 50090-5248 | metronidazole | metronidazole | A-S Medication Solutions | ANDA | Current |
| 50090-5248 | metronidazole | metronidazole | A-S Medication Solutions | ANDA | Current |
| 50090-5248 | metronidazole | metronidazole | A-S Medication Solutions | ANDA | Current |
| 50090-5249 | metronidazole | metronidazole | A-S Medication Solutions | ANDA | Current |
| 50090-5249 | metronidazole | metronidazole | A-S Medication Solutions | ANDA | Current |
| 50090-5250 | metronidazole | metronidazole | A-S Medication Solutions | ANDA | Current |
| 50090-5250 | metronidazole | metronidazole | A-S Medication Solutions | ANDA | Current |
| 50090-5307 | metronidazole | metronidazole | A-S Medication Solutions | ANDA | Current |
| 50090-5307 | metronidazole | metronidazole | A-S Medication Solutions | ANDA | Current |
| 60760-539 | metronidazole | metronidazole | ST. MARY'S MEDICAL PARK PHARMACY | ANDA | Current |
| 67296-1605 | metronidazole | metronidazole | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1605 | metronidazole | metronidazole | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1747 | metronidazole | metronidazole | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1747 | metronidazole | metronidazole | RedPharm Drug, Inc. | ANDA | Current |
| 68071-2409 | metronidazole | metronidazole | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2449 | metronidazole | metronidazole | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2549 | metronidazole | metronidazole | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2551 | metronidazole | metronidazole | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68382-850 | metronidazole | metronidazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-850 | metronidazole | metronidazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-851 | metronidazole | metronidazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-851 | metronidazole | metronidazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68788-7815 | metronidazole | metronidazole | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7815 | metronidazole | metronidazole | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7815 | metronidazole | metronidazole | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7955 | metronidazole | metronidazole | Preferred Pharmaceuticals Inc | ANDA | Current |
| 68788-7955 | metronidazole | metronidazole | Preferred Pharmaceuticals Inc | ANDA | Current |
| 70518-2663 | metronidazole | metronidazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2663 | metronidazole | metronidazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2663 | metronidazole | metronidazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2663 | metronidazole | metronidazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2663 | metronidazole | metronidazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2663 | metronidazole | metronidazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2663 | metronidazole | metronidazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2663 | metronidazole | metronidazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2663 | metronidazole | metronidazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-3042 | metronidazole | metronidazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-3042 | metronidazole | metronidazole | REMEDYREPACK INC. | ANDA | Current |
| 70771-1045 | METRONIDAZOLE | METRONIDAZOLE | Cadila Healthcare Limited | ANDA | Current |
| 70771-1045 | METRONIDAZOLE | METRONIDAZOLE | Cadila Healthcare Limited | ANDA | Current |
| 70771-1046 | METRONIDAZOLE | METRONIDAZOLE | Cadila Healthcare Limited | ANDA | Current |
| 70771-1046 | METRONIDAZOLE | METRONIDAZOLE | Cadila Healthcare Limited | ANDA | Current |
| 70934-915 | metronidazole | metronidazole | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-915 | metronidazole | metronidazole | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71335-1703 | metronidazole | metronidazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1703 | metronidazole | metronidazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1703 | metronidazole | metronidazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1775 | metronidazole | metronidazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1775 | metronidazole | metronidazole | Bryant Ranch Prepack | ANDA | Current |
| 72578-007 | metronidazole | metronidazole | Viona Pharmaceuticals Inc | ANDA | Current |
| 72578-007 | metronidazole | metronidazole | Viona Pharmaceuticals Inc | ANDA | Current |
| 72578-007 | metronidazole | metronidazole | Viona Pharmaceuticals Inc | ANDA | Current |
| 72578-007 | metronidazole | metronidazole | Viona Pharmaceuticals Inc | ANDA | Current |
| 72578-008 | metronidazole | metronidazole | Viona Pharmaceuticals Inc | ANDA | Current |
| 72578-008 | metronidazole | metronidazole | Viona Pharmaceuticals Inc | ANDA | Current |
| 72578-008 | metronidazole | metronidazole | Viona Pharmaceuticals Inc | ANDA | Current |
| 72578-008 | metronidazole | metronidazole | Viona Pharmaceuticals Inc | ANDA | Current |
| 72789-195 | metronidazole | metronidazole | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-195 | metronidazole | metronidazole | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-195 | metronidazole | metronidazole | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-195 | metronidazole | metronidazole | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |