Application 075730
- Type
- ANDA
- Sponsor
- TEVA PARENTERAL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | THIOTEPA | THIOTEPA | INJECTABLE;INJECTION | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 002 | THIOTEPA | THIOTEPA | INJECTABLE;INJECTION | 30MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8778 | ORIG | 2001-04-20 |