Application 210275
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | POMALIDOMIDE | POMALIDOMIDE | CAPSULE;ORAL | 1MG | No | No |
| 002 | POMALIDOMIDE | POMALIDOMIDE | CAPSULE;ORAL | 2MG | No | No |
| 003 | POMALIDOMIDE | POMALIDOMIDE | CAPSULE;ORAL | 3MG | No | No |
| 004 | POMALIDOMIDE | POMALIDOMIDE | CAPSULE;ORAL | 4MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210275-001 | POMALIDOMIDE | POMALIDOMIDE | 1MG | CAPSULE / ORAL | 2022-01-26 | ||
| A210275-002 | POMALIDOMIDE | POMALIDOMIDE | 2MG | CAPSULE / ORAL | 2022-01-26 | ||
| A210275-003 | POMALIDOMIDE | POMALIDOMIDE | 3MG | CAPSULE / ORAL | 2022-01-26 | ||
| A210275-004 | POMALIDOMIDE | POMALIDOMIDE | 4MG | CAPSULE / ORAL | 2022-01-26 |
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 | A210275-001 | POMALIDOMIDE | 1MG | CAPSULE / ORAL | 2022-01-26 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A210275-002 | POMALIDOMIDE | 2MG | CAPSULE / ORAL | 2022-01-26 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A210275-003 | POMALIDOMIDE | 3MG | CAPSULE / ORAL | 2022-01-26 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A210275-004 | POMALIDOMIDE | 4MG | CAPSULE / ORAL | 2022-01-26 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A210275-001 | POMALIDOMIDE | 1MG | CAPSULE / ORAL | 2022-01-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A210275-002 | POMALIDOMIDE | 2MG | CAPSULE / ORAL | 2022-01-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A210275-003 | POMALIDOMIDE | 3MG | CAPSULE / ORAL | 2022-01-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A210275-004 | POMALIDOMIDE | 4MG | CAPSULE / ORAL | 2022-01-26 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210275-001 | POMALIDOMIDE | 1MG | CAPSULE / ORAL | 2022-01-26 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210275-002 | POMALIDOMIDE | 2MG | CAPSULE / ORAL | 2022-01-26 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210275-003 | POMALIDOMIDE | 3MG | CAPSULE / ORAL | 2022-01-26 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210275-004 | POMALIDOMIDE | 4MG | CAPSULE / ORAL | 2022-01-26 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210275-001 | POMALIDOMIDE | 1MG | CAPSULE / ORAL | 2022-01-26 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210275-002 | POMALIDOMIDE | 2MG | CAPSULE / ORAL | 2022-01-26 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210275-003 | POMALIDOMIDE | 3MG | CAPSULE / ORAL | 2022-01-26 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210275-004 | POMALIDOMIDE | 4MG | CAPSULE / ORAL | 2022-01-26 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210275-001 | POMALIDOMIDE | 1MG | CAPSULE / ORAL | 2022-01-26 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210275-002 | POMALIDOMIDE | 2MG | CAPSULE / ORAL | 2022-01-26 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210275-003 | POMALIDOMIDE | 3MG | CAPSULE / ORAL | 2022-01-26 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210275-004 | POMALIDOMIDE | 4MG | CAPSULE / ORAL | 2022-01-26 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210275-001 | POMALIDOMIDE | 1MG | CAPSULE / ORAL | 2022-01-26 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210275-002 | POMALIDOMIDE | 2MG | CAPSULE / ORAL | 2022-01-26 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210275-003 | POMALIDOMIDE | 3MG | CAPSULE / ORAL | 2022-01-26 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210275-004 | POMALIDOMIDE | 4MG | CAPSULE / ORAL | 2022-01-26 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210275-001 | POMALIDOMIDE | 1MG | CAPSULE / ORAL | 2022-01-26 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210275-002 | POMALIDOMIDE | 2MG | CAPSULE / ORAL | 2022-01-26 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210275-003 | POMALIDOMIDE | 3MG | CAPSULE / ORAL | 2022-01-26 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210275-004 | POMALIDOMIDE | 4MG | CAPSULE / ORAL | 2022-01-26 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210275-001 | POMALIDOMIDE | 1MG | CAPSULE / ORAL | 2022-01-26 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210275-002 | POMALIDOMIDE | 2MG | CAPSULE / ORAL | 2022-01-26 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210275-003 | POMALIDOMIDE | 3MG | CAPSULE / ORAL | 2022-01-26 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210275-004 | POMALIDOMIDE | 4MG | CAPSULE / ORAL | 2022-01-26 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210275-001 | POMALIDOMIDE | 1MG | CAPSULE / ORAL | 2022-01-26 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210275-002 | POMALIDOMIDE | 2MG | CAPSULE / ORAL | 2022-01-26 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210275-003 | POMALIDOMIDE | 3MG | CAPSULE / ORAL | 2022-01-26 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210275-004 | POMALIDOMIDE | 4MG | CAPSULE / ORAL | 2022-01-26 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210275-001 | POMALIDOMIDE | 1MG | CAPSULE / ORAL | 2022-01-26 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210275-002 | POMALIDOMIDE | 2MG | CAPSULE / ORAL | 2022-01-26 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210275-003 | POMALIDOMIDE | 3MG | CAPSULE / ORAL | 2022-01-26 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210275-004 | POMALIDOMIDE | 4MG | CAPSULE / ORAL | 2022-01-26 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-03-09 01:35 UTC | 2022-03 | A210275-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A210275-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A210275-003 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A210275-004 | 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 |
|---|---|---|---|---|---|---|
| Pomalidomide | POMALIDOMIDE | Sun Pharmaceutical Industries, Inc. | 3c222961-5398-4185-b2d0-defe90230094 | 2026-09-01 | Boxed warning, Warnings, Adverse reactions | Pomalidomide POMALIDOMIDE |
| Pomalidomide | POMALIDOMIDE | Cipla USA Inc. | a0c16478-1a0c-4be0-be75-cb9e4543d71a | 2026-08-13 | Boxed warning, Warnings, Adverse reactions | Pomalidomide POMALIDOMIDE |
| pomalidomide | POMALIDOMIDE | Dr. Reddy's Laboratories Inc. | 84678d19-fd8d-268e-2fe6-88e21195fcca | 2026-08-06 | Boxed warning, Warnings, Adverse reactions | pomalidomide POMALIDOMIDE |
| Pomalidomide | POMALIDOMIDE | Sandoz Inc | 4fcd4978-b2d1-4d1a-b239-717cddb8be1f | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | Pomalidomide POMALIDOMIDE |
| Pomalidomide | POMALIDOMIDE | Apotex Corp. | b1a1c713-d23b-5ede-1ae0-0bbba47221df | 2026-03-11 | Boxed warning, Warnings, Adverse reactions | Pomalidomide POMALIDOMIDE |
| Pomalidomide | POMALIDOMIDE | Breckenridge Pharmaceutical, Inc. | 41400b90-b64e-447b-90f3-1cad58050eba | 2026-03-04 | Boxed warning, Warnings, Adverse reactions | Pomalidomide POMALIDOMIDE |
| Pomalidomide | POMALIDOMIDE | Camber Pharmaceuticals, Inc. | 52676691-e171-467c-ae55-b5dcc14062a4 | 2026-03-04 | Boxed warning, Warnings, Adverse reactions | Pomalidomide POMALIDOMIDE |
| Pomalidomide | POMALIDOMIDE | Aurobindo Pharma Limited | 1539fbf9-8281-4c7b-827b-9f53b50d9042 | 2026-01-30 | Boxed warning, Warnings, Adverse reactions | Pomalidomide POMALIDOMIDE |
| Pomalidomide | POMALIDOMIDE | Natco Pharma Limited | 0169dbda-53df-4cd9-b989-ff7544f1bdf5 | 2025-11-18 | Boxed warning, Warnings, Adverse reactions | Pomalidomide POMALIDOMIDE |
| Pomalidomide | POMALIDOMIDE | Teva Pharmaceuticals, Inc. | dee932c5-0c7c-45f0-b2bb-c027badee537 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | Pomalidomide POMALIDOMIDE |
| Pomalyst | POMALIDOMIDE | Celgene Corporation | 2b25ef01-5c9e-11e1-b86c-0800200c9a66 | 2025-02-26 | Boxed warning, Warnings, Adverse reactions | POMALIDOMIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76287 | ORIG | 2023-11-03 |