Application 021839
- Type
- BLA
- Sponsor
- IPSEN INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | INCRELEX | MECASERMIN RECOMBINANT | INJECTABLE;SUBCUTANEOUS | 40MG/4ML (10MG/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 15054-1040 | Increlex | mecasermin | Ipsen Biopharmaceuticals, Inc. | BLA | Current |
| 15054-1040 | Increlex | mecasermin | Ipsen Biopharmaceuticals, Inc. | NDA | Current |
| 15054-1040 | Increlex | mecasermin | Ipsen Biopharmaceuticals, Inc. | NDA | Current |
| 15054-1040 | Increlex | mecasermin | Ipsen Biopharmaceuticals, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 82807 | SUPPL | 2025-07-11 |
| 82776 | SUPPL | 2025-07-11 |
| 77911 | SUPPL | 2024-03-21 |
| 77856 | SUPPL | 2024-03-18 |
| 75912 | SUPPL | 2023-10-24 |
| 75893 | SUPPL | 2023-10-24 |
| 67759 | SUPPL | 2021-06-10 |
| 61168 | SUPPL | 2020-03-23 |
| 61142 | SUPPL | 2020-03-23 |
| 57299 | SUPPL | 2020-03-23 |
| 57286 | SUPPL | 2020-03-23 |
| 42321 | ORIG | 2020-03-23 |
| 37739 | SUPPL | 2020-03-23 |
| 37738 | SUPPL | 2020-03-23 |
| 37737 | SUPPL | 2020-03-23 |
| 28684 | SUPPL | 2020-03-23 |
| 28683 | SUPPL | 2020-03-23 |
| 28682 | SUPPL | 2020-03-23 |
| 28681 | SUPPL | 2020-03-23 |
| 16437 | SUPPL | 2020-03-23 |
| 16436 | SUPPL | 2020-03-23 |
| 16435 | ORIG | 2020-03-23 |
| 6279 | SUPPL | 2020-03-23 |
| 6278 | ORIG | 2020-03-23 |