Application 215755
- Type
- ANDA
- Sponsor
- STRIDES PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 25MG | No | No |
| 002 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 50MG | No | No |
| 003 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 75MG | No | No |
| 004 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 100MG | No | No |
| 005 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 150MG | No | No |
| 006 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 200MG | No | No |
| 007 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 225MG | No | No |
| 008 | 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 |
|---|---|---|---|---|---|---|---|
| A215755-001 | PREGABALIN | PREGABALIN | 25MG | CAPSULE / ORAL | 2023-04-26 | ||
| A215755-002 | PREGABALIN | PREGABALIN | 50MG | CAPSULE / ORAL | 2023-04-26 | ||
| A215755-003 | PREGABALIN | PREGABALIN | 75MG | CAPSULE / ORAL | 2023-04-26 | ||
| A215755-004 | PREGABALIN | PREGABALIN | 100MG | CAPSULE / ORAL | 2023-04-26 | ||
| A215755-005 | PREGABALIN | PREGABALIN | 150MG | CAPSULE / ORAL | 2023-04-26 | ||
| A215755-006 | PREGABALIN | PREGABALIN | 200MG | CAPSULE / ORAL | 2023-04-26 | ||
| A215755-007 | PREGABALIN | PREGABALIN | 225MG | CAPSULE / ORAL | 2023-04-26 | ||
| A215755-008 | PREGABALIN | PREGABALIN | 300MG | CAPSULE / ORAL | 2023-04-26 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A215755-001 | PREGABALIN | 25MG | CAPSULE / ORAL | 2023-04-26 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A215755-002 | PREGABALIN | 50MG | CAPSULE / ORAL | 2023-04-26 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A215755-003 | PREGABALIN | 75MG | CAPSULE / ORAL | 2023-04-26 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A215755-004 | PREGABALIN | 100MG | CAPSULE / ORAL | 2023-04-26 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A215755-005 | PREGABALIN | 150MG | CAPSULE / ORAL | 2023-04-26 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A215755-006 | PREGABALIN | 200MG | CAPSULE / ORAL | 2023-04-26 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A215755-007 | PREGABALIN | 225MG | CAPSULE / ORAL | 2023-04-26 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A215755-008 | PREGABALIN | 300MG | CAPSULE / ORAL | 2023-04-26 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A215755-001 | PREGABALIN | 25MG | CAPSULE / ORAL | 2023-04-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A215755-002 | PREGABALIN | 50MG | CAPSULE / ORAL | 2023-04-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A215755-003 | PREGABALIN | 75MG | CAPSULE / ORAL | 2023-04-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A215755-004 | PREGABALIN | 100MG | CAPSULE / ORAL | 2023-04-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A215755-005 | PREGABALIN | 150MG | CAPSULE / ORAL | 2023-04-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A215755-006 | PREGABALIN | 200MG | CAPSULE / ORAL | 2023-04-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A215755-007 | PREGABALIN | 225MG | CAPSULE / ORAL | 2023-04-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A215755-008 | PREGABALIN | 300MG | CAPSULE / ORAL | 2023-04-26 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A215755-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2023-04-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215755-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2023-04-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215755-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2023-04-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215755-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2023-04-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215755-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2023-04-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215755-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2023-04-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215755-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2023-04-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215755-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2023-04-26 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215755-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2023-04-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215755-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2023-04-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215755-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2023-04-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215755-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2023-04-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215755-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2023-04-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215755-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2023-04-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215755-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2023-04-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215755-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2023-04-26 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215755-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2023-04-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215755-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2023-04-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215755-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2023-04-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215755-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2023-04-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215755-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2023-04-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215755-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2023-04-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215755-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2023-04-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215755-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2023-04-26 | 6a471c1ec25d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A215755-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215755-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215755-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215755-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215755-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215755-006 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215755-007 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215755-008 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215755-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215755-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215755-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215755-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215755-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215755-006 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215755-007 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215755-008 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A215755-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A215755-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A215755-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A215755-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A215755-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A215755-006 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A215755-007 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A215755-008 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215755-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215755-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215755-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215755-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215755-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215755-006 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215755-007 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215755-008 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215755-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215755-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215755-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215755-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215755-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215755-006 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215755-007 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215755-008 | AB | 1 | b8a1b40f171c… |
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 | Clinical Solutions Wholesale, LLC | 613a7a13-d5ba-4827-91ec-3ed5176602b7 | 2026-02-13 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| PREGABALIN | PREGABALIN | REMEDYREPACK INC. | 1a8f13f6-0f4c-4194-ba37-b2d1a8fc4993 | 2026-02-09 | Warnings, Adverse reactions | PREGABALIN PREGABALIN |
| PREGABALIN | PREGABALIN | A-S Medication Solutions | 54a9bfb4-dcff-491d-9676-1fe1d05e004c | 2026-02-08 | Warnings, Adverse reactions | PREGABALIN PREGABALIN |
| Pregabalin | PREGABALIN | A-S Medication Solutions | 217c9f93-fe89-4684-8553-12ec9acaa507 | 2026-02-08 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | A-S Medication Solutions | 5d33e9c7-6d81-485b-bf4a-9a588eda5208 | 2026-02-08 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | A-S Medication Solutions | fa24fa02-e27d-476a-b6c4-93650aaaee68 | 2026-02-06 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | A-S Medication Solutions | 55b62778-0e6a-45e8-9ace-3f1d6eca4487 | 2026-02-06 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | 99c3d252-4d51-4679-aa61-e2d0b8238b38 | 2026-02-05 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Advagen Pharma Ltd. | 2ffee7e7-bfa0-4933-9baf-7df55080816e | 2026-02-04 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Coupler LLC | 463d31dd-ff14-cc89-e063-6294a90a2ea9 | 2026-01-15 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| PREGABALIN | PREGABALIN | Major Pharmaceuticals | 2420e2d7-c01a-4590-88c5-6fe5361747e9 | 2026-01-06 | Warnings, Adverse reactions | PREGABALIN PREGABALIN |
| PREGABALIN | PREGABALIN | Eskayef Pharmaceuticals Limited | 65d9e751-61c2-4741-85c0-2526cfdc765c | 2025-12-31 | Warnings, Adverse reactions | PREGABALIN PREGABALIN |
| Pregabalin | PREGABALIN | Ascend Laboratories, LLC | 1b731dd5-b000-4c38-bfc8-2505b076e316 | 2025-12-22 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Golden State Medical Supply, Inc. | 1ef735e8-467e-ed0d-e063-6294a90a210e | 2025-12-15 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | NorthStar RxLLC | 4a4d4c76-31c5-413b-be7c-82cb8091c19d | 2025-12-12 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | ScieGen Pharmaceuticals, Inc | 459f0d31-a73f-2c62-e063-6394a90a810c | 2025-12-10 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Advanced Rx of Tennessee, LLC | afc89689-bea9-92ec-e053-2995a90a7f21 | 2025-11-17 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Chartwell RX, LLC | 13d03119-e49b-482e-b5f9-d40dc3f4862e | 2025-11-12 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| PREGABALIN | PREGABALIN | Bryant Ranch Prepack | 335e3bcb-10a3-481b-ad95-ee9ceaa3689e | 2025-11-06 | Warnings, Adverse reactions | PREGABALIN PREGABALIN |
| Pregabalin | PREGABALIN | Westminster Pharmaceuticals, LLC | 6b0ee2cf-52c3-4052-bea0-1458a4233745 | 2025-10-31 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.