Application 209530
- Type
- ANDA
- Sponsor
- JUBILANT GENERICS
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 |
|---|---|---|---|---|---|---|---|
| A209530-001 | PREGABALIN | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2025-05-20 | |
| A209530-002 | PREGABALIN | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2025-05-20 | |
| A209530-003 | PREGABALIN | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2025-05-20 | |
| A209530-004 | PREGABALIN | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2025-05-20 | |
| A209530-005 | PREGABALIN | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2025-05-20 | |
| A209530-006 | PREGABALIN | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2025-05-20 | |
| A209530-007 | PREGABALIN | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2025-05-20 | |
| A209530-008 | PREGABALIN | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2025-05-20 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209530-001 | AB |
| A209530-002 | AB |
| A209530-003 | AB |
| A209530-004 | AB |
| A209530-005 | AB |
| A209530-006 | AB |
| A209530-007 | AB |
| A209530-008 | 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 | A209530-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2025-05-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209530-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2025-05-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209530-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2025-05-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209530-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2025-05-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209530-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2025-05-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209530-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2025-05-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209530-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2025-05-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209530-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2025-05-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209530-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2025-05-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209530-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2025-05-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209530-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2025-05-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209530-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2025-05-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209530-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2025-05-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209530-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2025-05-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209530-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2025-05-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209530-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2025-05-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209530-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2025-05-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209530-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2025-05-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209530-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2025-05-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209530-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2025-05-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209530-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2025-05-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209530-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2025-05-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209530-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2025-05-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209530-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2025-05-20 | 6a471c1ec25d… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209530-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2025-05-20 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209530-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2025-05-20 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209530-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2025-05-20 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209530-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2025-05-20 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209530-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2025-05-20 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209530-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2025-05-20 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209530-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2025-05-20 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209530-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2025-05-20 | 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 | A209530-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209530-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209530-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209530-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209530-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209530-006 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209530-007 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209530-008 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209530-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209530-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209530-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209530-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209530-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209530-006 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209530-007 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209530-008 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A209530-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209530-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209530-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209530-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209530-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209530-006 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209530-007 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209530-008 | AB | 1 | 6a471c1ec25d… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209530-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209530-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209530-003 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209530-004 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209530-005 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209530-006 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209530-007 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209530-008 | 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 | Bryant Ranch Prepack | 8a7acea4-108d-40d2-a2a7-36088be97248 | 2026-04-07 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | 025c3adb-5f6b-45f5-a4c6-cea8e57102e3 | 2026-04-07 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | 2ceccc4d-97e2-4eb0-841f-23609187710c | 2026-04-07 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | 247aedca-ae27-44c6-b32c-c95d26454566 | 2026-04-07 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | e1ed81bc-1597-4bc5-80cd-09977a154e4b | 2026-04-07 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | fd568ede-dac7-4910-bb18-65fb00f2636e | 2026-04-07 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Proficient Rx LP | 32789571-a566-46fa-ba41-bd3c86276ecf | 2026-04-01 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | ST. MARY'S MEDICAL PARK PHARMACY | 3dd7930b-f544-f18b-e063-6294a90a0541 | 2026-03-31 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | c60f6b1e-7a24-41b2-8435-e20583a732c6 | 2026-03-30 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | 52e36f66-4c4a-4fc5-968b-46879b7bf1db | 2026-03-30 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | df382975-73f1-4957-8959-177848f796f7 | 2026-03-30 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | 90b65884-4222-4011-b042-88b83e51c57a | 2026-03-30 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | dbf3647a-5ab1-450e-be5f-69b844185572 | 2026-03-30 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | be8d51d7-ae26-4fc7-9457-a4ad84523fd7 | 2026-03-30 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | 9053ff4e-cc47-4fa8-990a-4b0d539a480a | 2026-03-30 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | 36085f4e-91ae-458c-b0a0-81363112df01 | 2026-03-30 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | 47cc53e6-e679-4a01-babc-af301dd756f7 | 2026-03-30 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | 4db38263-899a-8405-e063-6294a90a4408 | 2026-03-25 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | 4ddf514f-3922-624b-e063-6394a90a8f6b | 2026-03-25 | Warnings, Adverse reactions | Pregabalin PREGABALIN |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | 4ddf7b9b-7b72-913c-e063-6394a90af3a4 | 2026-03-25 | Warnings, Adverse reactions | Pregabalin PREGABALIN |