Application 215813
- Type
- NDA
- Sponsor
- MERIDIAN LABORATORIES INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 10MG/ML | No | No |
| 002 | DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 20MG/2ML | No | No |
| 003 | DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 80MG/8ML | No | No |
| 004 | DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 160MG/16ML | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 80907 | SUPPL | 2025-02-04 |
| 78125 | SUPPL | 2024-04-12 |
| 78124 | SUPPL | 2024-04-12 |
| 78119 | SUPPL | 2024-04-12 |
| 78118 | SUPPL | 2024-04-12 |
| 74899 | ORIG | 2023-07-27 |
| 72717 | ORIG | 2022-11-25 |
| 72673 | ORIG | 2022-11-23 |