Application 213702
- Type
- NDA
- Sponsor
- PHARMA MAR USA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ZEPZELCA | LURBINECTEDIN | INJECTABLE;INJECTION | 4MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 68727-712 | ZEPZELCA | Lurbinectedin | Jazz Pharmaceuticals, Inc. | NDA | Current |
| 68727-712 | ZEPZELCA | Lurbinectedin | Jazz Pharmaceuticals, Inc. | NDA | Current |
| 68727-712 | ZEPZELCA | Lurbinectedin | Jazz Pharmaceuticals, Inc. | NDA | Current |
| 68727-712 | ZEPZELCA | Lurbinectedin | Jazz Pharmaceuticals, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85277 | SUPPL | 2026-03-06 |
| 85208 | SUPPL | 2026-03-03 |
| 83655 | SUPPL | 2025-10-03 |
| 83631 | SUPPL | 2025-10-02 |
| 82148 | SUPPL | 2025-05-05 |
| 82266 | SUPPL | 2025-04-30 |
| 74955 | SUPPL | 2023-07-31 |
| 74950 | SUPPL | 2023-07-31 |
| 70688 | SUPPL | 2022-04-05 |
| 70685 | SUPPL | 2022-04-04 |
| 63896 | ORIG | 2020-07-14 |
| 63576 | ORIG | 2020-06-16 |
| 63570 | ORIG | 2020-06-15 |