Application 211967
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PREGABALIN | PREGABALIN | TABLET, EXTENDED RELEASE;ORAL | 165MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A211967-001 | PREGABALIN | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-04 |
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 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-04 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-04 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-04 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-04 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-04 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-04 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-04 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-04 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-04 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-04 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-04 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-04 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-04 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-04 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-04 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-04 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-04 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-04 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-11-04 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-11-04 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-11-04 | 782e0a99824c… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-04 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-04 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-04 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-04 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-04 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-04 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-04 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-04 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-04 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-04 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-04 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-04 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-04 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A211967-001 | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-04 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-04-04 05:41 UTC | 2022-04 | A211967-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A211967-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A211967-001 | AB | 1 | 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 |
|---|---|---|---|---|---|---|
| Pregabalin | PREGABALIN | Proficient Rx LP | 38e80423-0194-4064-9447-abfd29fce1da | 2023-12-01 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | d2a98872-1a52-47e1-b4bd-0ff7d6272a92 | 2023-12-01 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | 27d02970-5f8b-4f4f-b89e-e42cc78ddaa3 | 2023-11-28 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Proficient Rx LP | 137ffe30-ff8b-409d-a719-6be19d4d9522 | 2023-10-01 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Proficient Rx LP | a17f03ea-9375-48fe-be32-f8df509f5fba | 2023-06-01 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Alembic Pharmaceuticals Limited | 78a36538-701d-4dd9-a7fc-87d505784c83 | 2023-05-12 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Proficient Rx LP | 1d76c6a3-7899-4dec-afcc-2b575dfa6c25 | 2023-02-01 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Proficient Rx LP | 920c57e0-ddfe-4750-b353-5f96b65443cf | 2023-01-01 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Tris Pharma Inc | 62aa850d-199c-44d5-a730-45f43efa850e | 2022-11-30 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | df80e09f-3d57-47a0-ba58-bb79e9ba1953 | 2022-11-29 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Asclemed USA, Inc. | 3d2464fb-b3ac-496e-b8a5-c2e8a902ce29 | 2022-10-12 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin Extended Release | PREGABALIN | ScieGen Pharmaceuticals, INC. | 1544a657-353c-47f8-96ac-a63fa78373f0 | 2022-09-19 | Warnings, Adverse reactions | PREGABALIN |
| Pregabalin | PREGABALIN | Proficient Rx LP | 65311ae9-e440-4650-b1b1-6f4495fda93c | 2022-09-01 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Proficient Rx LP | c7986739-3fc9-4a1d-8dd6-2e11cf1f3610 | 2022-08-01 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Proficient Rx LP | 68829d7b-ab40-429e-92dc-91f8a0d49afd | 2022-07-01 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| PREGABALIN | PREGABALIN | Patrin Pharma, Inc. | d92c94e5-e542-4177-afa8-fa00ba17634c | 2022-06-21 | Warnings, Adverse reactions | PREGABALIN PREGABALIN |
| Pregabalin | PREGABALIN | Proficient Rx LP | 89b8c2d2-4a99-4b97-8b82-c0c36cd0df1b | 2022-06-01 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Proficient Rx LP | a1545bbb-b337-4760-ab4c-fb76ab019337 | 2022-05-02 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Proficient Rx LP | 1503dd3b-688b-4702-8fc1-954b5ffe4235 | 2022-05-02 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Proficient Rx LP | 9b1472ac-8b79-4f22-ae50-3b0942bd62b1 | 2022-04-01 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.