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 | Advanced Rx of Tennessee, LLC | af739a0d-a3cd-754f-e053-2a95a90ad655 | 2024-12-31 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Advanced Rx Pharmacy of Tennessee, LLC | d28168cd-9b7a-f8df-e053-2995a90ad97f | 2024-12-31 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Advanced Rx Pharmacy of Tennessee, LLC | b8172d6b-a646-e559-e053-2a95a90ac24d | 2024-12-31 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Advanced Rx Pharmacy of Tennessee, LLC | bc1b143d-feaf-9498-e053-2995a90acf50 | 2024-12-31 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Advanced Rx Pharmacy of Tennessee, LLC | b817083c-b535-2269-e053-2a95a90af5b9 | 2024-12-31 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Advanced Rx Pharmacy of Tennessee, LLC | c6b456ca-9d07-7789-e053-2a95a90a20c5 | 2024-12-31 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Advanced Rx Pharmacy of Tennessee, LLC | c8bfc4f9-6208-4eaa-e053-2a95a90ada97 | 2024-12-31 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Advanced Rx Pharmacy of Tennessee, LLC | c8acdbcf-3076-63b2-e053-2a95a90aa3c4 | 2024-12-31 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Advanced Rx Pharmacy of Tennessee, LLC | c89a3514-f637-e54f-e053-2a95a90a6881 | 2024-12-31 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Advanced Rx Pharmacy of Tennessee, LLC | d2804923-a466-6dc6-e053-2a95a90a4182 | 2024-12-31 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Advanced Rx Pharmacy of Tennessee, LLC | f5d9b625-783c-bd78-e053-2995a90a37d2 | 2024-12-31 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Advanced Rx Pharmacy of Tennessee, LLC | f8ae62be-3a68-be6b-e053-6394a90ab627 | 2024-12-31 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | 29b91992-c853-a57d-e063-6394a90ab365 | 2024-12-20 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Quality Care Products, LLC | 59432752-c8d8-4396-95dd-0e04c55bc82b | 2024-12-19 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Quality Care Products, LLC | 1e087436-0534-4de2-b310-a5cc0e46adbd | 2024-12-18 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| PREGABALIN | PREGABALIN | Quality Care Products, LLC | ff386af0-17d3-4f95-803b-b51cb79e5295 | 2024-12-18 | Warnings, Adverse reactions | PREGABALIN PREGABALIN |
| PREGABALIN | PREGABALIN | Advanced Rx Pharmacy of Tennessee, LLC | d2813712-d7f6-6144-e053-2995a90a3c5d | 2024-11-20 | Warnings, Adverse reactions | PREGABALIN PREGABALIN |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | 4cda70e8-9ae1-4958-8c86-1bc633be982b | 2024-09-06 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | cf7f0fd0-bac2-4836-9363-79d32ad0cc10 | 2024-09-06 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | 08ad87e3-e00c-46d1-98f8-df493cf1712e | 2024-09-06 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.