Application 213405
- Type
- ANDA
- Sponsor
- TORRENT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LENALIDOMIDE | LENALIDOMIDE | CAPSULE;ORAL | 10MG | No | No |
| 002 | LENALIDOMIDE | LENALIDOMIDE | CAPSULE;ORAL | 25MG | No | No |
| 003 | LENALIDOMIDE | LENALIDOMIDE | CAPSULE;ORAL | 20MG | No | No |
| 004 | LENALIDOMIDE | LENALIDOMIDE | CAPSULE;ORAL | 15MG | No | No |
| 005 | LENALIDOMIDE | LENALIDOMIDE | CAPSULE;ORAL | 2.5MG | No | No |
| 006 | LENALIDOMIDE | LENALIDOMIDE | CAPSULE;ORAL | 5MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213405-001 | LENALIDOMIDE | LENALIDOMIDE | 10MG | CAPSULE / ORAL | 2023-02-17 | ||
| A213405-002 | LENALIDOMIDE | LENALIDOMIDE | 25MG | CAPSULE / ORAL | 2023-02-17 | ||
| A213405-003 | LENALIDOMIDE | LENALIDOMIDE | 20MG | CAPSULE / ORAL | 2023-08-03 | ||
| A213405-004 | LENALIDOMIDE | LENALIDOMIDE | 15MG | CAPSULE / ORAL | 2025-11-04 | ||
| A213405-005 | LENALIDOMIDE | LENALIDOMIDE | 2.5MG | CAPSULE / ORAL | 2026-02-10 | ||
| A213405-006 | LENALIDOMIDE | LENALIDOMIDE | 5MG | CAPSULE / ORAL | 2026-02-10 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A213405-001 | LENALIDOMIDE | 10MG | CAPSULE / ORAL | 2023-02-17 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213405-002 | LENALIDOMIDE | 25MG | CAPSULE / ORAL | 2023-02-17 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213405-003 | LENALIDOMIDE | 20MG | CAPSULE / ORAL | 2023-08-03 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213405-004 | LENALIDOMIDE | 15MG | CAPSULE / ORAL | AB | 2025-11-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213405-005 | LENALIDOMIDE | 2.5MG | CAPSULE / ORAL | AB | 2026-02-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213405-006 | LENALIDOMIDE | 5MG | CAPSULE / ORAL | AB | 2026-02-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213405-001 | LENALIDOMIDE | 10MG | CAPSULE / ORAL | 2023-02-17 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213405-002 | LENALIDOMIDE | 25MG | CAPSULE / ORAL | 2023-02-17 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213405-003 | LENALIDOMIDE | 20MG | CAPSULE / ORAL | 2023-08-03 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213405-004 | LENALIDOMIDE | 15MG | CAPSULE / ORAL | AB | 2025-11-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213405-001 | LENALIDOMIDE | 10MG | CAPSULE / ORAL | 2023-02-17 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A213405-002 | LENALIDOMIDE | 25MG | CAPSULE / ORAL | 2023-02-17 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A213405-003 | LENALIDOMIDE | 20MG | CAPSULE / ORAL | 2023-08-03 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213405-001 | LENALIDOMIDE | 10MG | CAPSULE / ORAL | 2023-02-17 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213405-002 | LENALIDOMIDE | 25MG | CAPSULE / ORAL | 2023-02-17 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213405-003 | LENALIDOMIDE | 20MG | CAPSULE / ORAL | 2023-08-03 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213405-001 | LENALIDOMIDE | 10MG | CAPSULE / ORAL | 2023-02-17 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213405-002 | LENALIDOMIDE | 25MG | CAPSULE / ORAL | 2023-02-17 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213405-003 | LENALIDOMIDE | 20MG | CAPSULE / ORAL | 2023-08-03 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213405-001 | LENALIDOMIDE | 10MG | CAPSULE / ORAL | 2023-02-17 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213405-002 | LENALIDOMIDE | 25MG | CAPSULE / ORAL | 2023-02-17 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213405-003 | LENALIDOMIDE | 20MG | CAPSULE / ORAL | 2023-08-03 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213405-001 | LENALIDOMIDE | 10MG | CAPSULE / ORAL | 2023-02-17 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213405-002 | LENALIDOMIDE | 25MG | CAPSULE / ORAL | 2023-02-17 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213405-003 | LENALIDOMIDE | 20MG | CAPSULE / ORAL | 2023-08-03 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213405-001 | LENALIDOMIDE | 10MG | CAPSULE / ORAL | 2023-02-17 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213405-002 | LENALIDOMIDE | 25MG | CAPSULE / ORAL | 2023-02-17 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213405-003 | LENALIDOMIDE | 20MG | CAPSULE / ORAL | 2023-08-03 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213405-001 | LENALIDOMIDE | 10MG | CAPSULE / ORAL | 2023-02-17 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213405-002 | LENALIDOMIDE | 25MG | CAPSULE / ORAL | 2023-02-17 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213405-003 | LENALIDOMIDE | 20MG | CAPSULE / ORAL | 2023-08-03 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A213405-001 | LENALIDOMIDE | 10MG | CAPSULE / ORAL | 2023-02-17 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A213405-002 | LENALIDOMIDE | 25MG | CAPSULE / ORAL | 2023-02-17 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A213405-003 | LENALIDOMIDE | 20MG | CAPSULE / ORAL | 2023-08-03 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213405-001 | LENALIDOMIDE | 10MG | CAPSULE / ORAL | 2023-02-17 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213405-002 | LENALIDOMIDE | 25MG | CAPSULE / ORAL | 2023-02-17 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213405-003 | LENALIDOMIDE | 20MG | CAPSULE / ORAL | 2023-08-03 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213405-001 | LENALIDOMIDE | 10MG | CAPSULE / ORAL | 2023-02-17 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213405-002 | LENALIDOMIDE | 25MG | CAPSULE / ORAL | 2023-02-17 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213405-003 | LENALIDOMIDE | 20MG | CAPSULE / ORAL | 2023-08-03 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A213405-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213405-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213405-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213405-004 | AB | 1 | 31067a03dcf5… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A213405-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A213405-002 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A213405-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A213405-002 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A213405-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A213405-002 | AB | 1 | 053a50430f4f… |
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 |
|---|---|---|---|---|---|---|
| Lenalidomide | LENALIDOMIDE | Teva Pharmaceuticals, Inc. | 1b2716cf-24b4-4157-a218-58ede63917bd | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | Lenalidomide LENALIDOMIDE |
| LENALIDOMIDE | LENALIDOMIDE | Amneal Pharmaceuticals NY LLC | da7b5dda-79ed-4c4a-88aa-52394fdc7c54 | 2026-05-14 | Boxed warning, Warnings, Adverse reactions | LENALIDOMIDE LENALIDOMIDE |
| Lenalidomide | LENALIDOMIDE | Accord Healthcare Inc. | 9c414531-a3bf-455a-aca7-9e716f42099a | 2026-05-07 | Boxed warning, Warnings, Adverse reactions | Lenalidomide LENALIDOMIDE |
| Lenalidomide | LENALIDOMIDE | Devatis Inc. | 9959cd7e-12b6-4b59-8205-d5f6e7e7d09b | 2026-02-03 | Boxed warning, Warnings, Adverse reactions | Lenalidomide LENALIDOMIDE |
| Lenalidomide | LENALIDOMIDE | Novugen Pharma (USA) LLC | 2166bbdf-eb12-4564-b9e4-b63ca21312bc | 2025-12-05 | Boxed warning, Warnings, Adverse reactions | Lenalidomide LENALIDOMIDE |
| LENALIDOMIDE | LENALIDOMIDE | Alvogen, Inc. | adee5af1-c9ab-c0c7-e400-dea7d2a0d4be | 2025-11-05 | Boxed warning, Warnings, Adverse reactions | LENALIDOMIDE LENALIDOMIDE |
| Lenalidomide | LENALIDOMIDE | Apotex Corp. | 9943e098-20b0-dbb3-af12-7816eedd3f70 | 2025-09-19 | Boxed warning, Warnings, Adverse reactions | Lenalidomide LENALIDOMIDE |
| LENALIDOMIDE | LENALIDOMIDE | Padagis US LLC | dffe719b-4f61-47e2-b71c-673322d487f5 | 2025-08-25 | Boxed warning, Warnings, Adverse reactions | LENALIDOMIDE LENALIDOMIDE |
| Lenalidomide | LENALIDOMIDE | BIOCON PHARMA INC., | ed7a3099-ce31-4865-b212-358d9ff6261b | 2025-03-03 | Boxed warning, Warnings, Adverse reactions | Lenalidomide LENALIDOMIDE |
| lenalidomide | LENALIDOMIDE | Cipla USA Inc. | ba2a07fd-ca60-40bc-b79b-9caf81900fa3 | 2025-01-02 | Boxed warning, Warnings, Adverse reactions | lenalidomide LENALIDOMIDE |
| Lenalidomide | LENALIDOMIDE | Sun Pharmaceutical Industries, Inc. | 84d9dec7-9250-4dbd-9a0d-23e75f111892 | 2024-12-13 | Boxed warning, Warnings, Adverse reactions | Lenalidomide LENALIDOMIDE |
| LENALIDOMIDE | LENALIDOMIDE | Zydus Lifesciences Limited | fd23328f-b019-4c14-80d9-4ebd997f26b2 | 2024-11-30 | LENALIDOMIDE LENALIDOMIDE | |
| LENALIDOMIDE | LENALIDOMIDE | Camber Pharmaceuticals, Inc. | f27092f3-3977-4f4a-b214-45309e136e46 | 2024-08-07 | Boxed warning, Warnings, Adverse reactions | LENALIDOMIDE LENALIDOMIDE |
| lenalidomide | LENALIDOMIDE | EXELAN PHARMACEUTICALS INC. | 682e8a86-9f49-45db-a2ea-403ee1dc62d2 | 2024-06-21 | Boxed warning, Warnings, Adverse reactions | lenalidomide LENALIDOMIDE |
| LENALIDOMIDE | LENALIDOMIDE | EXELAN PHARMACEUTICALS INC. | 85f5db5d-8f76-46f6-b975-6acda8c4b2c8 | 2024-06-12 | Warnings, Adverse reactions | LENALIDOMIDE LENALIDOMIDE |
| LENALIDOMIDE | LENALIDOMIDE | Zydus Pharmaceuticals USA Inc. | c98fb504-76d0-4c25-9c0b-412885828a7a | 2024-02-10 | Boxed warning, Warnings, Adverse reactions | LENALIDOMIDE LENALIDOMIDE |
| Lenalidomide | LENALIDOMIDE | Mylan Pharmaceuticals Inc. | 76f6c1e7-985b-43d9-892c-849df50ae80e | 2023-10-31 | Boxed warning, Warnings, Adverse reactions | Lenalidomide LENALIDOMIDE |
| Lenalidomide | LENALIDOMIDE | Aurobindo Pharma Limited | 51bfdd53-8fd9-4f86-bebe-75de29e6379d | 2023-06-29 | Boxed warning, Warnings, Adverse reactions | Lenalidomide LENALIDOMIDE |
| Lenalidomide | LENALIDOMIDE | Dr. Reddy's Laboratories Inc. | ca8cc2cc-c856-e676-4f60-1e46d7b53d73 | 2023-04-30 | Boxed warning, Warnings, Adverse reactions | Lenalidomide LENALIDOMIDE |
| Revlimid | LENALIDOMIDE | Celgene Corporation | 5fa97bf5-28a2-48f1-8955-f56012d296be | 2023-03-24 | Boxed warning, Warnings, Adverse reactions | LENALIDOMIDE |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76347 | ORIG | 2023-11-06 |