Application 212280
- Type
- ANDA
- Sponsor
- CIPLA
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 |
|---|---|---|---|---|---|---|---|
| A212280-001 | PREGABALIN | PREGABALIN | 25MG | CAPSULE / ORAL | 2020-01-10 | ||
| A212280-002 | PREGABALIN | PREGABALIN | 50MG | CAPSULE / ORAL | 2020-01-10 | ||
| A212280-003 | PREGABALIN | PREGABALIN | 75MG | CAPSULE / ORAL | 2020-01-10 | ||
| A212280-004 | PREGABALIN | PREGABALIN | 100MG | CAPSULE / ORAL | 2020-01-10 | ||
| A212280-005 | PREGABALIN | PREGABALIN | 150MG | CAPSULE / ORAL | 2020-01-10 | ||
| A212280-006 | PREGABALIN | PREGABALIN | 200MG | CAPSULE / ORAL | 2020-01-10 | ||
| A212280-007 | PREGABALIN | PREGABALIN | 225MG | CAPSULE / ORAL | 2020-01-10 | ||
| A212280-008 | PREGABALIN | PREGABALIN | 300MG | CAPSULE / ORAL | 2020-01-10 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A212280-001 | PREGABALIN | 25MG | CAPSULE / ORAL | 2020-01-10 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A212280-002 | PREGABALIN | 50MG | CAPSULE / ORAL | 2020-01-10 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A212280-003 | PREGABALIN | 75MG | CAPSULE / ORAL | 2020-01-10 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A212280-004 | PREGABALIN | 100MG | CAPSULE / ORAL | 2020-01-10 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A212280-005 | PREGABALIN | 150MG | CAPSULE / ORAL | 2020-01-10 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A212280-006 | PREGABALIN | 200MG | CAPSULE / ORAL | 2020-01-10 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A212280-007 | PREGABALIN | 225MG | CAPSULE / ORAL | 2020-01-10 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A212280-008 | PREGABALIN | 300MG | CAPSULE / ORAL | 2020-01-10 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212280-001 | PREGABALIN | 25MG | CAPSULE / ORAL | 2020-01-10 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212280-002 | PREGABALIN | 50MG | CAPSULE / ORAL | 2020-01-10 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212280-003 | PREGABALIN | 75MG | CAPSULE / ORAL | 2020-01-10 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212280-004 | PREGABALIN | 100MG | CAPSULE / ORAL | 2020-01-10 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212280-005 | PREGABALIN | 150MG | CAPSULE / ORAL | 2020-01-10 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212280-006 | PREGABALIN | 200MG | CAPSULE / ORAL | 2020-01-10 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212280-007 | PREGABALIN | 225MG | CAPSULE / ORAL | 2020-01-10 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212280-008 | PREGABALIN | 300MG | CAPSULE / ORAL | 2020-01-10 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212280-001 | PREGABALIN | 25MG | CAPSULE / ORAL | 2020-01-10 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212280-002 | PREGABALIN | 50MG | CAPSULE / ORAL | 2020-01-10 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212280-003 | PREGABALIN | 75MG | CAPSULE / ORAL | 2020-01-10 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212280-004 | PREGABALIN | 100MG | CAPSULE / ORAL | 2020-01-10 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212280-005 | PREGABALIN | 150MG | CAPSULE / ORAL | 2020-01-10 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212280-006 | PREGABALIN | 200MG | CAPSULE / ORAL | 2020-01-10 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212280-007 | PREGABALIN | 225MG | CAPSULE / ORAL | 2020-01-10 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212280-008 | PREGABALIN | 300MG | CAPSULE / ORAL | 2020-01-10 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212280-001 | PREGABALIN | 25MG | CAPSULE / ORAL | 2020-01-10 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212280-002 | PREGABALIN | 50MG | CAPSULE / ORAL | 2020-01-10 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212280-003 | PREGABALIN | 75MG | CAPSULE / ORAL | 2020-01-10 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212280-004 | PREGABALIN | 100MG | CAPSULE / ORAL | 2020-01-10 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212280-005 | PREGABALIN | 150MG | CAPSULE / ORAL | 2020-01-10 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212280-006 | PREGABALIN | 200MG | CAPSULE / ORAL | 2020-01-10 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212280-007 | PREGABALIN | 225MG | CAPSULE / ORAL | 2020-01-10 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212280-008 | PREGABALIN | 300MG | CAPSULE / ORAL | 2020-01-10 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212280-001 | PREGABALIN | 25MG | CAPSULE / ORAL | 2020-01-10 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212280-002 | PREGABALIN | 50MG | CAPSULE / ORAL | 2020-01-10 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212280-003 | PREGABALIN | 75MG | CAPSULE / ORAL | 2020-01-10 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212280-004 | PREGABALIN | 100MG | CAPSULE / ORAL | 2020-01-10 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212280-005 | PREGABALIN | 150MG | CAPSULE / ORAL | 2020-01-10 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212280-006 | PREGABALIN | 200MG | CAPSULE / ORAL | 2020-01-10 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212280-007 | PREGABALIN | 225MG | CAPSULE / ORAL | 2020-01-10 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212280-008 | PREGABALIN | 300MG | CAPSULE / ORAL | 2020-01-10 | fd3edfee7708… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-05-31 18:47 UTC | 2024-05 | A212280-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A212280-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A212280-003 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A212280-004 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A212280-005 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A212280-006 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A212280-007 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A212280-008 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212280-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212280-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212280-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212280-004 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212280-005 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212280-006 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212280-007 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212280-008 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A212280-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A212280-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A212280-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A212280-004 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A212280-005 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A212280-006 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A212280-007 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A212280-008 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A212280-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A212280-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A212280-003 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A212280-004 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A212280-005 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A212280-006 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A212280-007 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A212280-008 | AB | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A212280-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A212280-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A212280-003 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A212280-004 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A212280-005 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A212280-006 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A212280-007 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A212280-008 | AB | 1 | bb7c543d1eb4… |
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 capsules, CV | PREGABALIN CAPSULES, CV | Cipla USA Inc. | 7d93359c-1849-430d-a922-21d42932d0f3 | 2025-12-22 | Warnings, Adverse reactions | 212280 ANDA212280 69097-681 69097-683 69097-682 69097-685 69097-677 69097-679 69097-684 69097-678 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-5938 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | A-S Medication Solutions | ANDA | Current |
| 69097-677 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-677 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-677 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-677 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-678 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-678 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-678 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-678 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-679 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-679 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-679 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-679 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-681 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-681 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-681 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-681 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-682 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-682 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-682 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-682 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-683 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-683 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-683 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-683 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-684 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-684 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-684 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-684 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-685 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-685 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-685 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-685 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |