Skip to contentApplication 211022
- Type
- ANDA
- Sponsor
- APOTEX INC
Application Products#
Product, Drug, Ingredient table| 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 |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| 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 |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76341 | ORIG | 2023-11-06 |
| 69654 | ORIG | 2021-12-20 |