Application 091157
- Type
- ANDA
- Sponsor
- SUN PHARM
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 |
|---|---|---|---|---|---|---|---|
| A091157-001 | PREGABALIN | PREGABALIN | 25MG | CAPSULE / ORAL | 2019-11-29 | ||
| A091157-002 | PREGABALIN | PREGABALIN | 50MG | CAPSULE / ORAL | 2019-11-29 | ||
| A091157-003 | PREGABALIN | PREGABALIN | 75MG | CAPSULE / ORAL | 2019-11-29 | ||
| A091157-004 | PREGABALIN | PREGABALIN | 100MG | CAPSULE / ORAL | 2019-11-29 | ||
| A091157-005 | PREGABALIN | PREGABALIN | 150MG | CAPSULE / ORAL | 2019-11-29 | ||
| A091157-006 | PREGABALIN | PREGABALIN | 200MG | CAPSULE / ORAL | 2019-11-29 | ||
| A091157-007 | PREGABALIN | PREGABALIN | 225MG | CAPSULE / ORAL | 2019-11-29 | ||
| A091157-008 | PREGABALIN | PREGABALIN | 300MG | CAPSULE / ORAL | 2019-11-29 |
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 | A091157-001 | PREGABALIN | 25MG | CAPSULE / ORAL | 2019-11-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091157-002 | PREGABALIN | 50MG | CAPSULE / ORAL | 2019-11-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091157-003 | PREGABALIN | 75MG | CAPSULE / ORAL | 2019-11-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091157-004 | PREGABALIN | 100MG | CAPSULE / ORAL | 2019-11-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091157-005 | PREGABALIN | 150MG | CAPSULE / ORAL | 2019-11-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091157-006 | PREGABALIN | 200MG | CAPSULE / ORAL | 2019-11-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091157-007 | PREGABALIN | 225MG | CAPSULE / ORAL | 2019-11-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091157-008 | PREGABALIN | 300MG | CAPSULE / ORAL | 2019-11-29 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091157-001 | PREGABALIN | 25MG | CAPSULE / ORAL | 2019-11-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091157-002 | PREGABALIN | 50MG | CAPSULE / ORAL | 2019-11-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091157-003 | PREGABALIN | 75MG | CAPSULE / ORAL | 2019-11-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091157-004 | PREGABALIN | 100MG | CAPSULE / ORAL | 2019-11-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091157-005 | PREGABALIN | 150MG | CAPSULE / ORAL | 2019-11-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091157-006 | PREGABALIN | 200MG | CAPSULE / ORAL | 2019-11-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091157-007 | PREGABALIN | 225MG | CAPSULE / ORAL | 2019-11-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091157-008 | PREGABALIN | 300MG | CAPSULE / ORAL | 2019-11-29 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091157-001 | PREGABALIN | 25MG | CAPSULE / ORAL | 2019-11-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091157-002 | PREGABALIN | 50MG | CAPSULE / ORAL | 2019-11-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091157-003 | PREGABALIN | 75MG | CAPSULE / ORAL | 2019-11-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091157-004 | PREGABALIN | 100MG | CAPSULE / ORAL | 2019-11-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091157-005 | PREGABALIN | 150MG | CAPSULE / ORAL | 2019-11-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091157-006 | PREGABALIN | 200MG | CAPSULE / ORAL | 2019-11-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091157-007 | PREGABALIN | 225MG | CAPSULE / ORAL | 2019-11-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091157-008 | PREGABALIN | 300MG | CAPSULE / ORAL | 2019-11-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091157-001 | PREGABALIN | 25MG | CAPSULE / ORAL | 2019-11-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091157-002 | PREGABALIN | 50MG | CAPSULE / ORAL | 2019-11-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091157-003 | PREGABALIN | 75MG | CAPSULE / ORAL | 2019-11-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091157-004 | PREGABALIN | 100MG | CAPSULE / ORAL | 2019-11-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091157-005 | PREGABALIN | 150MG | CAPSULE / ORAL | 2019-11-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091157-006 | PREGABALIN | 200MG | CAPSULE / ORAL | 2019-11-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091157-007 | PREGABALIN | 225MG | CAPSULE / ORAL | 2019-11-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091157-008 | PREGABALIN | 300MG | CAPSULE / ORAL | 2019-11-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091157-001 | PREGABALIN | 25MG | CAPSULE / ORAL | 2019-11-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091157-002 | PREGABALIN | 50MG | CAPSULE / ORAL | 2019-11-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091157-003 | PREGABALIN | 75MG | CAPSULE / ORAL | 2019-11-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091157-004 | PREGABALIN | 100MG | CAPSULE / ORAL | 2019-11-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091157-005 | PREGABALIN | 150MG | CAPSULE / ORAL | 2019-11-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091157-006 | PREGABALIN | 200MG | CAPSULE / ORAL | 2019-11-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091157-007 | PREGABALIN | 225MG | CAPSULE / ORAL | 2019-11-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091157-008 | PREGABALIN | 300MG | CAPSULE / ORAL | 2019-11-29 | 6a471c1ec25d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091157-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091157-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091157-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091157-004 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091157-005 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091157-006 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091157-007 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091157-008 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A091157-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A091157-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A091157-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A091157-004 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A091157-005 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A091157-006 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A091157-007 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A091157-008 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A091157-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A091157-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A091157-003 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A091157-004 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A091157-005 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A091157-006 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A091157-007 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A091157-008 | AB | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A091157-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A091157-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A091157-003 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A091157-004 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A091157-005 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A091157-006 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A091157-007 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A091157-008 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A091157-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A091157-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A091157-003 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A091157-004 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A091157-005 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A091157-006 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A091157-007 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A091157-008 | AB | 1 | 782e0a99824c… |
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 | Sun Pharmaceutical Industries, Inc. | ee7b9119-e88f-48ad-ae97-55e53374e62f | 2023-12-21 | Warnings, Adverse reactions | 091157 ANDA091157 47335-689 47335-693 47335-687 47335-690 47335-691 47335-686 47335-688 47335-692 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 47335-686 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-686 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-686 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-686 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-686 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-687 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-687 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-687 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-687 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-687 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-688 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-688 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-688 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-688 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-688 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-689 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-689 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-689 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-689 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-689 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-690 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-690 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-690 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-690 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-690 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-691 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-691 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-691 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-691 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-691 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-692 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-692 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-692 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-692 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-692 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-693 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-693 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-693 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-693 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-693 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |