Application 211022
- Type
- ANDA
- Sponsor
- APOTEX INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LENALIDOMIDE | LENALIDOMIDE | CAPSULE;ORAL | 5MG | No | No |
| 002 | LENALIDOMIDE | LENALIDOMIDE | CAPSULE;ORAL | 10MG | No | No |
| 003 | LENALIDOMIDE | LENALIDOMIDE | CAPSULE;ORAL | 15MG | No | No |
| 004 | LENALIDOMIDE | LENALIDOMIDE | CAPSULE;ORAL | 25MG | No | No |
| 005 | LENALIDOMIDE | LENALIDOMIDE | CAPSULE;ORAL | 2.5MG | No | No |
| 006 | LENALIDOMIDE | LENALIDOMIDE | CAPSULE;ORAL | 20MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A211022-001 | LENALIDOMIDE | LENALIDOMIDE | 5MG | CAPSULE / ORAL | AB | 2022-08-30 | |
| A211022-002 | LENALIDOMIDE | LENALIDOMIDE | 10MG | CAPSULE / ORAL | AB | 2022-08-30 | |
| A211022-003 | LENALIDOMIDE | LENALIDOMIDE | 15MG | CAPSULE / ORAL | AB | 2022-08-30 | |
| A211022-004 | LENALIDOMIDE | LENALIDOMIDE | 25MG | CAPSULE / ORAL | AB | 2022-08-30 | |
| A211022-005 | LENALIDOMIDE | LENALIDOMIDE | 2.5MG | CAPSULE / ORAL | AB | 2023-03-07 | |
| A211022-006 | LENALIDOMIDE | LENALIDOMIDE | 20MG | CAPSULE / ORAL | AB | 2023-03-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A211022-001 | AB |
| A211022-002 | AB |
| A211022-003 | AB |
| A211022-004 | AB |
| A211022-005 | AB |
| A211022-006 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A211022-001 | LENALIDOMIDE | 5MG | CAPSULE / ORAL | AB | 2022-08-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A211022-002 | LENALIDOMIDE | 10MG | CAPSULE / ORAL | AB | 2022-08-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A211022-003 | LENALIDOMIDE | 15MG | CAPSULE / ORAL | AB | 2022-08-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A211022-004 | LENALIDOMIDE | 25MG | CAPSULE / ORAL | AB | 2022-08-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A211022-005 | LENALIDOMIDE | 2.5MG | CAPSULE / ORAL | AB | 2023-03-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A211022-006 | LENALIDOMIDE | 20MG | CAPSULE / ORAL | AB | 2023-03-07 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A211022-001 | LENALIDOMIDE | 5MG | CAPSULE / ORAL | AB | 2022-08-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211022-002 | LENALIDOMIDE | 10MG | CAPSULE / ORAL | AB | 2022-08-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211022-003 | LENALIDOMIDE | 15MG | CAPSULE / ORAL | AB | 2022-08-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211022-004 | LENALIDOMIDE | 25MG | CAPSULE / ORAL | AB | 2022-08-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211022-005 | LENALIDOMIDE | 2.5MG | CAPSULE / ORAL | AB | 2023-03-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211022-006 | LENALIDOMIDE | 20MG | CAPSULE / ORAL | AB | 2023-03-07 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211022-001 | LENALIDOMIDE | 5MG | CAPSULE / ORAL | AB | 2022-08-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211022-002 | LENALIDOMIDE | 10MG | CAPSULE / ORAL | AB | 2022-08-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211022-003 | LENALIDOMIDE | 15MG | CAPSULE / ORAL | AB | 2022-08-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211022-004 | LENALIDOMIDE | 25MG | CAPSULE / ORAL | AB | 2022-08-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211022-005 | LENALIDOMIDE | 2.5MG | CAPSULE / ORAL | AB | 2023-03-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211022-006 | LENALIDOMIDE | 20MG | CAPSULE / ORAL | AB | 2023-03-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211022-001 | LENALIDOMIDE | 5MG | CAPSULE / ORAL | AB | 2022-08-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211022-002 | LENALIDOMIDE | 10MG | CAPSULE / ORAL | AB | 2022-08-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211022-003 | LENALIDOMIDE | 15MG | CAPSULE / ORAL | AB | 2022-08-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211022-004 | LENALIDOMIDE | 25MG | CAPSULE / ORAL | AB | 2022-08-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211022-005 | LENALIDOMIDE | 2.5MG | CAPSULE / ORAL | AB | 2023-03-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211022-006 | LENALIDOMIDE | 20MG | CAPSULE / ORAL | AB | 2023-03-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211022-001 | LENALIDOMIDE | 5MG | CAPSULE / ORAL | AB | 2022-08-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211022-002 | LENALIDOMIDE | 10MG | CAPSULE / ORAL | AB | 2022-08-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211022-003 | LENALIDOMIDE | 15MG | CAPSULE / ORAL | AB | 2022-08-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211022-004 | LENALIDOMIDE | 25MG | CAPSULE / ORAL | AB | 2022-08-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211022-005 | LENALIDOMIDE | 2.5MG | CAPSULE / ORAL | AB | 2023-03-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211022-006 | LENALIDOMIDE | 20MG | CAPSULE / ORAL | AB | 2023-03-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211022-001 | LENALIDOMIDE | 5MG | CAPSULE / ORAL | AB | 2022-08-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211022-002 | LENALIDOMIDE | 10MG | CAPSULE / ORAL | AB | 2022-08-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211022-003 | LENALIDOMIDE | 15MG | CAPSULE / ORAL | AB | 2022-08-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211022-004 | LENALIDOMIDE | 25MG | CAPSULE / ORAL | AB | 2022-08-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211022-005 | LENALIDOMIDE | 2.5MG | CAPSULE / ORAL | AB | 2023-03-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211022-006 | LENALIDOMIDE | 20MG | CAPSULE / ORAL | AB | 2023-03-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211022-001 | LENALIDOMIDE | 5MG | CAPSULE / ORAL | AB | 2022-08-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211022-002 | LENALIDOMIDE | 10MG | CAPSULE / ORAL | AB | 2022-08-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211022-003 | LENALIDOMIDE | 15MG | CAPSULE / ORAL | AB | 2022-08-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211022-004 | LENALIDOMIDE | 25MG | CAPSULE / ORAL | AB | 2022-08-30 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A211022-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211022-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211022-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211022-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211022-005 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211022-006 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A211022-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211022-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211022-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211022-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211022-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211022-006 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A211022-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211022-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211022-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211022-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211022-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211022-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211022-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211022-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211022-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211022-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211022-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211022-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A211022-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211022-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211022-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211022-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211022-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211022-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211022-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211022-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211022-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211022-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211022-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211022-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211022-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211022-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211022-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211022-004 | AB | 1 | b8a1b40f171c… |
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 | 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 |
| Lenalidomide | LENALIDOMIDE | Cipla USA Inc. | 96df285d-dd13-4083-b2c6-e5c799e7587b | 2022-05-31 | Boxed warning, Warnings, Adverse reactions | Lenalidomide LENALIDOMIDE |
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 |
|---|---|---|---|---|---|
| 60505-4533 | Lenalidomide | Lenalidomide | Apotex Corp. | ANDA | Current |
| 60505-4534 | Lenalidomide | Lenalidomide | Apotex Corp. | ANDA | Current |
| 60505-4535 | Lenalidomide | Lenalidomide | Apotex Corp. | ANDA | Current |
| 60505-4537 | Lenalidomide | Lenalidomide | Apotex Corp. | ANDA | Current |