Application 206942
- Type
- ANDA
- Sponsor
- TORRENT 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 |
|---|---|---|---|---|---|---|---|
| A206942-001 | PREGABALIN | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2025-02-21 | |
| A206942-002 | PREGABALIN | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2025-02-21 | |
| A206942-003 | PREGABALIN | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2025-02-21 | |
| A206942-004 | PREGABALIN | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2025-02-21 | |
| A206942-005 | PREGABALIN | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2025-02-21 | |
| A206942-006 | PREGABALIN | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2025-02-21 | |
| A206942-007 | PREGABALIN | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2025-02-21 | |
| A206942-008 | PREGABALIN | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2025-02-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A206942-001 | AB |
| A206942-002 | AB |
| A206942-003 | AB |
| A206942-004 | AB |
| A206942-005 | AB |
| A206942-006 | AB |
| A206942-007 | AB |
| A206942-008 | 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 | A206942-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2025-02-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206942-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2025-02-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206942-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2025-02-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206942-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2025-02-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206942-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2025-02-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206942-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2025-02-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206942-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2025-02-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206942-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2025-02-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206942-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2025-02-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206942-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2025-02-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206942-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2025-02-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206942-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2025-02-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206942-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2025-02-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206942-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2025-02-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206942-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2025-02-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206942-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2025-02-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206942-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2025-02-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206942-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2025-02-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206942-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2025-02-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206942-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2025-02-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206942-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2025-02-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206942-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2025-02-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206942-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2025-02-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206942-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2025-02-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206942-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2025-02-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206942-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2025-02-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206942-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2025-02-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206942-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2025-02-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206942-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2025-02-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206942-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2025-02-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206942-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2025-02-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206942-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2025-02-21 | fd3edfee7708… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A206942-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2025-02-21 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A206942-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2025-02-21 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A206942-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2025-02-21 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A206942-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2025-02-21 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A206942-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2025-02-21 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A206942-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2025-02-21 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A206942-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2025-02-21 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A206942-008 | 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 | A206942-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206942-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206942-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206942-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206942-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206942-006 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206942-007 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206942-008 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206942-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206942-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206942-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206942-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206942-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206942-006 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206942-007 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206942-008 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A206942-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206942-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206942-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206942-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206942-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206942-006 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206942-007 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206942-008 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206942-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206942-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206942-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206942-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206942-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206942-006 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206942-007 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206942-008 | AB | 1 | fd3edfee7708… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A206942-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A206942-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A206942-003 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A206942-004 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A206942-005 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A206942-006 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A206942-007 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A206942-008 | 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 | Torrent Pharmaceuticals Limited | a062e78a-16ff-4d83-b700-0badb7d812d5 | 2026-03-11 | Warnings, Adverse reactions | 206942 ANDA206942 |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | 4ccb0d75-d7d9-471c-8737-8552e9e57efa | 2026-03-05 | Warnings, Adverse reactions | 206942 ANDA206942 |