Application 215577
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PREGABALIN | PREGABALIN | TABLET, EXTENDED RELEASE;ORAL | 82.5MG | No | No |
| 002 | PREGABALIN | PREGABALIN | TABLET, EXTENDED RELEASE;ORAL | 165MG | No | No |
| 003 | PREGABALIN | PREGABALIN | TABLET, EXTENDED RELEASE;ORAL | 330MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A215577-001 | PREGABALIN | PREGABALIN | 82.5MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | ||
| A215577-002 | PREGABALIN | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | ||
| A215577-003 | PREGABALIN | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215577-002 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215577-003 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215577-001 | PREGABALIN | 82.5MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215577-002 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215577-003 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215577-001 | PREGABALIN | 82.5MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215577-002 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215577-003 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A215577-001 | PREGABALIN | 82.5MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A215577-002 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A215577-003 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | 8072bd15b7f6… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215577-001 | PREGABALIN | 82.5MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215577-002 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215577-003 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A215577-001 | PREGABALIN | 82.5MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A215577-002 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A215577-003 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A215577-001 | PREGABALIN | 82.5MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A215577-002 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A215577-003 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215577-001 | PREGABALIN | 82.5MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215577-002 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215577-003 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215577-001 | PREGABALIN | 82.5MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215577-002 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215577-003 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215577-001 | PREGABALIN | 82.5MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215577-002 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215577-003 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215577-001 | PREGABALIN | 82.5MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215577-002 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215577-003 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A215577-001 | PREGABALIN | 82.5MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A215577-002 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A215577-003 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-26 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A215577-001 | PREGABALIN | 82.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-08-26 | 3bdfa0b2c4d7… | |
| 2023-01-26 05:58 UTC | 2023-01 | A215577-002 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-08-26 | 3bdfa0b2c4d7… | |
| 2023-01-26 05:58 UTC | 2023-01 | A215577-003 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-08-26 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A215577-001 | PREGABALIN | 82.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-08-26 | 3a93d1ddd44b… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A215577-002 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-08-26 | 3a93d1ddd44b… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2023-01-26 05:58 UTC | 2023-01 | A215577-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A215577-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A215577-003 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A215577-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A215577-002 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A215577-003 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A215577-001 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A215577-002 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A215577-003 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A215577-001 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A215577-002 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A215577-003 | AB | 1 | e64feba35796… |
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 |
|---|---|---|---|---|---|---|
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | ab06a36d-9a2d-4eae-8991-4eab5bc8311c | 2026-09-11 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Clinical Solutions Wholesale, LLC | 93c2fe8b-67d7-4a15-8790-5595e158b3ab | 2026-09-09 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | e897d7e8-2743-4512-8417-375cb11ceec6 | 2026-09-03 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | 84bf3abb-559d-4140-a689-f3e26b1c4ff2 | 2026-09-02 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | St. Mary's Medical Park Pharmacy | 923745e9-17a2-a5f7-e053-2a95a90aed38 | 2026-09-01 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Preferred Pharmaceuticals Inc. | 7f29991e-3bf5-4e48-8fa3-6d4e932ed6de | 2026-08-21 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Preferred Pharmaceuticals, Inc. | ce1419bc-c348-4407-b320-e0598d5a7b19 | 2026-08-21 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | d095accf-9cea-4948-b43d-ae1b8fbce7c2 | 2026-08-20 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | 12309847-0857-4ff7-a7e7-edeadc3dfb61 | 2026-08-14 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | 47d08b8f-a24d-4159-ab43-2eb67a93559b | 2026-08-14 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | 3c8ea6da-5771-4096-a915-700e51ced05c | 2026-08-14 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | 9c38abbc-2b3d-48d6-b629-4a163c803db5 | 2026-08-14 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | efe06a26-30c5-437d-9fd1-4bd0062f1200 | 2026-08-14 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | f30a7a3b-d45e-4e0b-ab1b-1369b2f02320 | 2026-08-06 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | 326c643a-23c5-4dab-9266-abc22ca1f874 | 2026-08-06 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | 5d738807-7f88-4943-9c3b-01f1e52ea72d | 2026-08-05 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Ascend Laboratories, LLC | e48db3c2-7351-41f2-a451-5a8341c4125c | 2026-08-04 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | 9685792b-911d-4cf9-9881-d21abca48c66 | 2026-08-03 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | c60752f8-20d5-4333-bf33-a656eab01d6b | 2026-08-03 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | 0f72ec70-314c-4c9f-86be-54f3e010356d | 2026-08-03 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.