Application 091222
- Type
- ANDA
- Sponsor
- WOCKHARDT USA
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 |
|---|---|---|---|---|---|---|---|
| A091222-001 | PREGABALIN | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2025-02-21 | |
| A091222-002 | PREGABALIN | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2025-02-21 | |
| A091222-003 | PREGABALIN | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2025-02-21 | |
| A091222-004 | PREGABALIN | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2025-02-21 | |
| A091222-005 | PREGABALIN | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2025-02-21 | |
| A091222-006 | PREGABALIN | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2025-02-21 | |
| A091222-007 | PREGABALIN | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2025-02-21 | |
| A091222-008 | PREGABALIN | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2025-02-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091222-001 | AB |
| A091222-002 | AB |
| A091222-003 | AB |
| A091222-004 | AB |
| A091222-005 | AB |
| A091222-006 | AB |
| A091222-007 | AB |
| A091222-008 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A091222-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2025-02-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091222-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2025-02-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091222-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2025-02-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091222-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2025-02-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091222-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2025-02-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091222-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2025-02-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091222-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2025-02-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091222-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2025-02-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091222-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2025-02-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091222-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2025-02-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091222-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2025-02-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091222-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2025-02-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091222-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2025-02-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091222-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2025-02-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091222-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2025-02-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091222-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2025-02-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091222-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2025-02-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091222-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2025-02-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091222-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2025-02-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091222-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2025-02-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091222-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2025-02-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091222-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2025-02-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091222-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2025-02-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091222-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2025-02-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091222-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2025-02-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091222-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2025-02-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091222-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2025-02-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091222-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2025-02-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091222-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2025-02-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091222-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2025-02-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091222-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2025-02-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091222-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2025-02-21 | fd3edfee7708… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A091222-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2025-02-21 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A091222-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2025-02-21 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A091222-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2025-02-21 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A091222-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2025-02-21 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A091222-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2025-02-21 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A091222-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2025-02-21 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A091222-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2025-02-21 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A091222-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2025-02-21 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A091222-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091222-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091222-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091222-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091222-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091222-006 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091222-007 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091222-008 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091222-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091222-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091222-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091222-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091222-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091222-006 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091222-007 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091222-008 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091222-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091222-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091222-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091222-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091222-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091222-006 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091222-007 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091222-008 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091222-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091222-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091222-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091222-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091222-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091222-006 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091222-007 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091222-008 | AB | 1 | fd3edfee7708… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A091222-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A091222-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A091222-003 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A091222-004 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A091222-005 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A091222-006 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A091222-007 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A091222-008 | AB | 1 | a50c72e98297… |
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 | REMEDYREPACK INC. | 91edbe87-cd22-43a5-9952-1cd523b13820 | 2026-07-29 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | 14f3f9ba-7a4a-45d5-a25e-efe5cdff117d | 2026-07-28 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | 44ec2918-4e0c-4e2d-9157-81295a15df57 | 2026-07-28 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | 1e6fa742-f658-495f-88bb-8eddf9a45ffe | 2026-07-27 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | 48798c13-3ef4-4e7f-9f73-92dccac0af14 | 2026-07-24 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| PREGABALIN | PREGABALIN | Cardinal Health 107, LLC | 124176c7-d8ab-4bbe-b468-3e5d12f03e44 | 2026-07-21 | Warnings, Adverse reactions | PREGABALIN PREGABALIN |
| Pregabalin | PREGABALIN | St. Mary's Medical Park Pharmacy | fc5dd378-950f-949b-e053-6394a90a3ca2 | 2026-07-17 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | St. Mary's Medical Park Pharmacy | 9235cd08-7a25-4b81-e053-2995a90a539c | 2026-07-02 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Proficient Rx LP | 189b610e-3e29-42fa-ab6e-73effbe0d054 | 2026-07-01 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | St. Mary's Medical Park Pharmacy | 35d3486c-c6ea-4d31-e063-6294a90a1219 | 2026-06-30 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | St. Mary's Medical Park Pharmacy | 35d387dd-bc7f-37a4-e063-6394a90abbbb | 2026-06-30 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | St. Mary's Medical Park Pharmacy | 36c3dda1-67fb-4dc5-e063-6294a90a1c3e | 2026-06-26 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | St. Mary's Medical Park Pharmacy | 2c62e63a-fe81-a463-e063-6394a90a65ee | 2026-06-26 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | St. Mary's Medical Park Pharmacy | 2e6e6f9c-a14c-2d75-e063-6294a90a827e | 2026-06-20 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | ba3006b7-991f-4ae0-b908-5910e827e5bf | 2026-06-12 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | d095accf-9cea-4948-b43d-ae1b8fbce7c2 | 2026-06-11 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Clinical Solutions Wholesale, LLC | 150c8b71-98b0-4c6b-b20f-fd0fca2d3c26 | 2026-06-11 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| PREGABALIN | PREGABALIN | Novadoz Pharmaceuticals LLC | f6aa5977-97c8-4a56-8e35-d9ab5cc24369 | 2026-06-10 | Warnings, Adverse reactions | PREGABALIN PREGABALIN |
| Pregabalin | PREGABALIN | Coupler LLC | 5383c0de-0c85-f702-e063-6294a90a1d8d | 2026-06-05 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | ST. MARY'S MEDICAL PARK PHARMACY | 923743f0-f557-9143-e053-2a95a90a21ae | 2026-06-05 | Warnings, Adverse reactions | Pregabalin PREGABALIN |