Application 091224
- Type
- ANDA
- Sponsor
- TEVA PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 75MG | No | No |
| 002 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 100MG | No | No |
| 003 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 150MG | No | No |
| 004 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 200MG | No | No |
| 005 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 225MG | No | No |
| 006 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 300MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091224-001 | PREGABALIN | PREGABALIN | 75MG | CAPSULE / ORAL | 2019-07-19 | ||
| A091224-002 | PREGABALIN | PREGABALIN | 100MG | CAPSULE / ORAL | 2019-07-19 | ||
| A091224-003 | PREGABALIN | PREGABALIN | 150MG | CAPSULE / ORAL | 2019-07-19 | ||
| A091224-004 | PREGABALIN | PREGABALIN | 200MG | CAPSULE / ORAL | 2019-07-19 | ||
| A091224-005 | PREGABALIN | PREGABALIN | 225MG | CAPSULE / ORAL | 2019-07-19 | ||
| A091224-006 | PREGABALIN | PREGABALIN | 300MG | CAPSULE / ORAL | 2019-07-19 |
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 | A091224-001 | PREGABALIN | 75MG | CAPSULE / ORAL | 2019-07-19 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091224-002 | PREGABALIN | 100MG | CAPSULE / ORAL | 2019-07-19 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091224-003 | PREGABALIN | 150MG | CAPSULE / ORAL | 2019-07-19 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091224-004 | PREGABALIN | 200MG | CAPSULE / ORAL | 2019-07-19 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091224-005 | PREGABALIN | 225MG | CAPSULE / ORAL | 2019-07-19 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091224-006 | PREGABALIN | 300MG | CAPSULE / ORAL | 2019-07-19 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091224-001 | PREGABALIN | 75MG | CAPSULE / ORAL | 2019-07-19 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091224-002 | PREGABALIN | 100MG | CAPSULE / ORAL | 2019-07-19 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091224-003 | PREGABALIN | 150MG | CAPSULE / ORAL | 2019-07-19 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091224-004 | PREGABALIN | 200MG | CAPSULE / ORAL | 2019-07-19 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091224-005 | PREGABALIN | 225MG | CAPSULE / ORAL | 2019-07-19 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091224-006 | PREGABALIN | 300MG | CAPSULE / ORAL | 2019-07-19 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091224-001 | PREGABALIN | 75MG | CAPSULE / ORAL | 2019-07-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091224-002 | PREGABALIN | 100MG | CAPSULE / ORAL | 2019-07-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091224-003 | PREGABALIN | 150MG | CAPSULE / ORAL | 2019-07-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091224-004 | PREGABALIN | 200MG | CAPSULE / ORAL | 2019-07-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091224-005 | PREGABALIN | 225MG | CAPSULE / ORAL | 2019-07-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091224-006 | PREGABALIN | 300MG | CAPSULE / ORAL | 2019-07-19 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091224-001 | PREGABALIN | 75MG | CAPSULE / ORAL | 2019-07-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091224-002 | PREGABALIN | 100MG | CAPSULE / ORAL | 2019-07-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091224-003 | PREGABALIN | 150MG | CAPSULE / ORAL | 2019-07-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091224-004 | PREGABALIN | 200MG | CAPSULE / ORAL | 2019-07-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091224-005 | PREGABALIN | 225MG | CAPSULE / ORAL | 2019-07-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091224-006 | PREGABALIN | 300MG | CAPSULE / ORAL | 2019-07-19 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091224-001 | PREGABALIN | 75MG | CAPSULE / ORAL | 2019-07-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091224-002 | PREGABALIN | 100MG | CAPSULE / ORAL | 2019-07-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091224-003 | PREGABALIN | 150MG | CAPSULE / ORAL | 2019-07-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091224-004 | PREGABALIN | 200MG | CAPSULE / ORAL | 2019-07-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091224-005 | PREGABALIN | 225MG | CAPSULE / ORAL | 2019-07-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091224-006 | PREGABALIN | 300MG | CAPSULE / ORAL | 2019-07-19 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091224-001 | PREGABALIN | 75MG | CAPSULE / ORAL | 2019-07-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091224-002 | PREGABALIN | 100MG | CAPSULE / ORAL | 2019-07-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091224-003 | PREGABALIN | 150MG | CAPSULE / ORAL | 2019-07-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091224-004 | PREGABALIN | 200MG | CAPSULE / ORAL | 2019-07-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091224-005 | PREGABALIN | 225MG | CAPSULE / ORAL | 2019-07-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091224-006 | PREGABALIN | 300MG | CAPSULE / ORAL | 2019-07-19 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091224-001 | PREGABALIN | 75MG | CAPSULE / ORAL | 2019-07-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091224-002 | PREGABALIN | 100MG | CAPSULE / ORAL | 2019-07-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091224-003 | PREGABALIN | 150MG | CAPSULE / ORAL | 2019-07-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091224-004 | PREGABALIN | 200MG | CAPSULE / ORAL | 2019-07-19 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091224-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091224-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091224-003 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091224-004 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091224-005 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091224-006 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091224-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091224-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091224-003 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091224-004 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091224-005 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091224-006 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091224-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091224-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091224-003 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091224-004 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091224-005 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091224-006 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A091224-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A091224-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A091224-003 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A091224-004 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A091224-005 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A091224-006 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091224-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091224-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091224-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091224-004 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091224-005 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091224-006 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A091224-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A091224-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A091224-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A091224-004 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A091224-005 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A091224-006 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A091224-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A091224-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A091224-003 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A091224-004 | AB | 1 | 4b0b4de00fa7… |
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 | Aphena Pharma Solutions - Tennessee, LLC | 14c00449-c3b8-d6ba-e063-6294a90ab627 | 2025-10-27 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | ScieGen Pharmaceuticals, Inc | 33ef1a3b-554f-4a51-afdb-92a019e8c16c | 2025-10-15 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| PREGABALIN | PREGABALIN | Creekwood Pharmaceuticals LLC | bfe4108e-b2d2-4059-be16-21d3276c3ae4 | 2025-10-09 | Warnings, Adverse reactions | PREGABALIN PREGABALIN |
| Pregabalin | PREGABALIN | AvPAK | 40c0f658-2a0a-034b-e063-6394a90a1097 | 2025-10-09 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | bf710bcf-75ed-4184-b9c3-81cd05a780a4 | 2025-10-09 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | b5b22ec1-3fd8-4631-ba7e-98d8e5d030b3 | 2025-10-02 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Westminster Pharmaceuticals, LLC | 781cb1ac-a0d2-4b47-b319-f0b90de86384 | 2025-10-01 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Proficient Rx LP | 7d25bec8-b503-4f63-8995-372a6df58c72 | 2025-10-01 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| PREGABALIN | PREGABALIN | Bryant Ranch Prepack | 3ce4dfdf-e32f-40e8-9a13-e45d51539e08 | 2025-09-30 | Warnings, Adverse reactions | PREGABALIN PREGABALIN |
| Pregabalin | PREGABALIN | Camber Pharmaceuticals, Inc. | 241c4b7e-f719-4828-8639-ea613b8a6583 | 2025-09-29 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| PREGABALIN | PREGABALIN | Bryant Ranch Prepack | ca861bfb-caef-4764-bad5-c95a0d035475 | 2025-09-23 | Warnings, Adverse reactions | PREGABALIN PREGABALIN |
| PREGABALIN | PREGABALIN | Bryant Ranch Prepack | 0101cd1f-4a95-40e9-86a8-ccde8d656e3d | 2025-09-23 | Warnings, Adverse reactions | PREGABALIN PREGABALIN |
| PREGABALIN | PREGABALIN | Bryant Ranch Prepack | 311e748a-7db4-4967-989b-5ed96871d99a | 2025-09-23 | Warnings, Adverse reactions | PREGABALIN PREGABALIN |
| PREGABALIN | PREGABALIN | Bryant Ranch Prepack | ff55a40e-4a5a-40db-87b1-7ece1d5b316f | 2025-09-23 | Warnings, Adverse reactions | PREGABALIN PREGABALIN |
| PREGABALIN | PREGABALIN | Bryant Ranch Prepack | 72832f05-325e-4a72-8a33-da114e39c52d | 2025-09-23 | Warnings, Adverse reactions | PREGABALIN PREGABALIN |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | 3f002a7f-e632-e58f-e063-6394a90abce8 | 2025-09-17 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | 3f00c179-336d-e534-e063-6294a90a9141 | 2025-09-17 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Preferred Pharmaceuticals, Inc. | 8ac0689e-47a3-44d7-bf98-a919c302726d | 2025-09-15 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Preferred Pharmaceuticals Inc. | dc50f01d-1802-4666-8f2f-35980a40990f | 2025-09-15 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Preferred Pharmaceuticals, Inc. | 25345672-1368-4e3a-95b2-ca45fe120294 | 2025-09-12 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-7621 | Pregabalin | Pregabalin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7621 | Pregabalin | Pregabalin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7621 | Pregabalin | Pregabalin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7624 | Pregabalin | Pregabalin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7624 | Pregabalin | Pregabalin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7625 | Pregabalin | Pregabalin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7625 | Pregabalin | Pregabalin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7626 | Pregabalin | Pregabalin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7626 | Pregabalin | Pregabalin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7626 | Pregabalin | Pregabalin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7627 | Pregabalin | Pregabalin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7627 | Pregabalin | Pregabalin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7627 | Pregabalin | Pregabalin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7628 | Pregabalin | Pregabalin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7628 | Pregabalin | Pregabalin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7628 | Pregabalin | Pregabalin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |