Application 213049
- Type
- ANDA
- Sponsor
- MSN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | THIOTEPA | THIOTEPA | POWDER;INTRAVENOUS | 15MG/VIAL | No | No |
| 002 | THIOTEPA | THIOTEPA | POWDER;INTRAVENOUS | 100MG/VIAL | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69539-123 | Thiotepa | Thiotepa | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-124 | Thiotepa | Thiotepa | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 72205-045 | Thiotepa | Thiotepa | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-046 | Thiotepa | Thiotepa | Novadoz Pharmaceuticals LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 63031 | ORIG | 2020-05-15 |