Application 205924
- Type
- ANDA
- Sponsor
- MACLEODS PHARMS LTD
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 |
|---|---|---|---|---|---|---|---|
| A205924-001 | PREGABALIN | PREGABALIN | 25MG | CAPSULE / ORAL | 2024-11-12 | ||
| A205924-002 | PREGABALIN | PREGABALIN | 50MG | CAPSULE / ORAL | 2024-11-12 | ||
| A205924-003 | PREGABALIN | PREGABALIN | 75MG | CAPSULE / ORAL | 2024-11-12 | ||
| A205924-004 | PREGABALIN | PREGABALIN | 100MG | CAPSULE / ORAL | 2024-11-12 | ||
| A205924-005 | PREGABALIN | PREGABALIN | 150MG | CAPSULE / ORAL | 2024-11-12 | ||
| A205924-006 | PREGABALIN | PREGABALIN | 200MG | CAPSULE / ORAL | 2024-11-12 | ||
| A205924-007 | PREGABALIN | PREGABALIN | 225MG | CAPSULE / ORAL | 2024-11-12 | ||
| A205924-008 | PREGABALIN | PREGABALIN | 300MG | CAPSULE / ORAL | 2024-11-12 |
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 | A205924-001 | PREGABALIN | 25MG | CAPSULE / ORAL | 2024-11-12 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A205924-002 | PREGABALIN | 50MG | CAPSULE / ORAL | 2024-11-12 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A205924-003 | PREGABALIN | 75MG | CAPSULE / ORAL | 2024-11-12 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A205924-004 | PREGABALIN | 100MG | CAPSULE / ORAL | 2024-11-12 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A205924-005 | PREGABALIN | 150MG | CAPSULE / ORAL | 2024-11-12 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A205924-006 | PREGABALIN | 200MG | CAPSULE / ORAL | 2024-11-12 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A205924-007 | PREGABALIN | 225MG | CAPSULE / ORAL | 2024-11-12 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A205924-008 | PREGABALIN | 300MG | CAPSULE / ORAL | 2024-11-12 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A205924-001 | PREGABALIN | 25MG | CAPSULE / ORAL | 2024-11-12 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A205924-002 | PREGABALIN | 50MG | CAPSULE / ORAL | 2024-11-12 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A205924-003 | PREGABALIN | 75MG | CAPSULE / ORAL | 2024-11-12 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A205924-004 | PREGABALIN | 100MG | CAPSULE / ORAL | 2024-11-12 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A205924-005 | PREGABALIN | 150MG | CAPSULE / ORAL | 2024-11-12 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A205924-006 | PREGABALIN | 200MG | CAPSULE / ORAL | 2024-11-12 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A205924-007 | PREGABALIN | 225MG | CAPSULE / ORAL | 2024-11-12 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A205924-008 | PREGABALIN | 300MG | CAPSULE / ORAL | 2024-11-12 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A205924-001 | PREGABALIN | 25MG | CAPSULE / ORAL | 2024-11-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A205924-002 | PREGABALIN | 50MG | CAPSULE / ORAL | 2024-11-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A205924-003 | PREGABALIN | 75MG | CAPSULE / ORAL | 2024-11-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A205924-004 | PREGABALIN | 100MG | CAPSULE / ORAL | 2024-11-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A205924-005 | PREGABALIN | 150MG | CAPSULE / ORAL | 2024-11-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A205924-006 | PREGABALIN | 200MG | CAPSULE / ORAL | 2024-11-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A205924-007 | PREGABALIN | 225MG | CAPSULE / ORAL | 2024-11-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A205924-008 | PREGABALIN | 300MG | CAPSULE / ORAL | 2024-11-12 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205924-001 | PREGABALIN | 25MG | CAPSULE / ORAL | 2024-11-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205924-002 | PREGABALIN | 50MG | CAPSULE / ORAL | 2024-11-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205924-003 | PREGABALIN | 75MG | CAPSULE / ORAL | 2024-11-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205924-004 | PREGABALIN | 100MG | CAPSULE / ORAL | 2024-11-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205924-005 | PREGABALIN | 150MG | CAPSULE / ORAL | 2024-11-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205924-006 | PREGABALIN | 200MG | CAPSULE / ORAL | 2024-11-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205924-007 | PREGABALIN | 225MG | CAPSULE / ORAL | 2024-11-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205924-008 | PREGABALIN | 300MG | CAPSULE / ORAL | 2024-11-12 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A205924-001 | PREGABALIN | 25MG | CAPSULE / ORAL | 2024-11-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A205924-002 | PREGABALIN | 50MG | CAPSULE / ORAL | 2024-11-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A205924-003 | PREGABALIN | 75MG | CAPSULE / ORAL | 2024-11-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A205924-004 | PREGABALIN | 100MG | CAPSULE / ORAL | 2024-11-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A205924-005 | PREGABALIN | 150MG | CAPSULE / ORAL | 2024-11-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A205924-006 | PREGABALIN | 200MG | CAPSULE / ORAL | 2024-11-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A205924-007 | PREGABALIN | 225MG | CAPSULE / ORAL | 2024-11-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A205924-008 | PREGABALIN | 300MG | CAPSULE / ORAL | 2024-11-12 | 6a471c1ec25d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205924-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205924-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205924-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205924-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205924-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205924-006 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205924-007 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205924-008 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205924-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205924-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205924-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205924-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205924-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205924-006 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205924-007 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205924-008 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205924-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205924-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205924-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205924-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205924-005 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205924-006 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205924-007 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205924-008 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205924-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205924-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205924-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205924-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205924-005 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205924-006 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205924-007 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205924-008 | AB | 1 | 2680178bc6a6… |
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 |
|---|---|---|---|---|---|---|
| Pregablin | PREGABLIN | Macleods Pharmaceuticals Limited | a3a94949-3060-4057-9b29-e06a808cbd76 | 2025-05-14 | Warnings, Adverse reactions | 205924 ANDA205924 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.