Application 210480
- Type
- ANDA
- Sponsor
- LOTUS PHARM CO LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LENALIDOMIDE | LENALIDOMIDE | CAPSULE;ORAL | 2.5MG | No | No |
| 002 | LENALIDOMIDE | LENALIDOMIDE | CAPSULE;ORAL | 5MG | No | No |
| 003 | LENALIDOMIDE | LENALIDOMIDE | CAPSULE;ORAL | 10MG | No | No |
| 004 | LENALIDOMIDE | LENALIDOMIDE | CAPSULE;ORAL | 15MG | No | No |
| 005 | LENALIDOMIDE | LENALIDOMIDE | CAPSULE;ORAL | 20MG | No | No |
| 006 | LENALIDOMIDE | LENALIDOMIDE | CAPSULE;ORAL | 25MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 47781-484 | LENALIDOMIDE | Lenalidomide | Alvogen, Inc. | ANDA | Current |
| 47781-485 | LENALIDOMIDE | Lenalidomide | Alvogen, Inc. | ANDA | Current |
| 47781-486 | LENALIDOMIDE | Lenalidomide | Alvogen, Inc. | ANDA | Current |
| 47781-488 | LENALIDOMIDE | Lenalidomide | Alvogen, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76343 | ORIG | 2023-11-06 |
| 65095 | ORIG | 2020-10-30 |