Application 211431
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | 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 |
|---|---|---|---|---|---|---|---|
| A211431-001 | PREGABALIN | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | 782e0a99824c… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A211431-001 | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | 2021-07-02 | a50c72e98297… |
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 | Bryant Ranch Prepack | 8923d776-b374-4c06-a208-abeffb1ba578 | 2024-09-06 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | fac0eb4e-12ef-4e8e-8cbe-c43c26f0faee | 2024-08-23 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Advanced Rx Pharmacy of Tennessee, LLC | f98c5df7-9b85-eacc-e053-6294a90a88ec | 2024-08-22 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | c72b0bed-b7b4-4ae1-914e-756d76b66ed9 | 2024-08-20 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | aac1f2f4-5ef5-49dd-b914-54f2cf2b1bc1 | 2024-08-12 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | b2d45d41-a787-4912-962d-0bd98b70d58a | 2024-08-12 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | 616b37d6-93d5-44de-a993-bddf59eaee9a | 2024-08-12 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | 8bb9495e-1354-4a70-baa5-9b80eb3518c8 | 2024-07-28 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | aa55a53c-96f6-4e0a-8b1d-e9d36e6ef2ec | 2024-07-28 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | 29a869b8-0d9f-4e3f-820a-061aa42ee482 | 2024-07-16 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | d70a5102-eb8d-45f1-acd0-692e9208428e | 2024-07-08 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | 59f94cd9-0fc9-4e55-8004-578971a1b42f | 2024-07-08 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | American Health Packaging | 59da1a16-d409-49eb-9b44-397c77006043 | 2024-06-13 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Advanced Rx of Tennessee, LLC | 1a15cd11-0db9-2bc8-e063-6394a90a11fb | 2024-06-05 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| PREGABALIN | PREGABALIN | Bryant Ranch Prepack | 15b5e3d0-2bad-4363-99cb-e15819c41fda | 2024-05-20 | Warnings, Adverse reactions | PREGABALIN PREGABALIN |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | 15ea709a-d502-41ea-e063-6394a90ad97d | 2024-04-12 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | 124d7552-e48d-b160-e063-6294a90a196f | 2024-02-26 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | 11fe25cd-1aca-0e63-e063-6394a90a197e | 2024-02-22 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | 4ed3e73c-13e7-4646-874d-276b6c75d2c9 | 2024-02-08 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Sun Pharmaceutical Industries, Inc. | ee7b9119-e88f-48ad-ae97-55e53374e62f | 2023-12-21 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.