Application 211488
- Type
- NDA
- Sponsor
- FORSEE PHARMACEUTICALS CO., LTD.
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CAMCEVI KIT | LEUPROLIDE MESYLATE | EMULSION;SUBCUTANEOUS | EQ 42 MG BASE | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 69448-014 | CAMCEVI | LEUPROLIDE | Accord BioPharma, Inc. | NDA | Current |
| 69448-014 | CAMCEVI | LEUPROLIDE | Accord BioPharma, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85048 | SUPPL | 2026-02-13 |
| 85041 | SUPPL | 2026-02-13 |
| 83474 | SUPPL | 2025-09-25 |
| 83463 | SUPPL | 2025-09-25 |
| 81247 | SUPPL | 2025-02-14 |
| 81228 | SUPPL | 2025-02-12 |
| 81227 | SUPPL | 2025-02-12 |
| 77827 | SUPPL | 2024-03-14 |
| 77826 | SUPPL | 2024-03-14 |
| 69081 | ORIG | 2021-10-25 |
| 67654 | ORIG | 2021-06-02 |
| 67602 | ORIG | 2021-05-26 |