Application 214222
- Type
- ANDA
- Sponsor
- GLAND PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | THIOTEPA | THIOTEPA | POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL | 15MG/VIAL | No | No |
| 002 | THIOTEPA | THIOTEPA | POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL | 100MG/VIAL | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 43598-171 | Thiotepa | Thiotepa | Dr.Reddy's Laboratories Inc., | ANDA | Current |
| 65219-029 | Thiotepa | Thiotepa | Fresenius Kabi USA, LLC | ANDA | Current |
| 68083-446 | Thiotepa | Thiotepa | Gland Pharma Limited | ANDA | Current |
| 68083-446 | Thiotepa | Thiotepa | Gland Pharma Limited | ANDA | Current |
| 68083-503 | Thiotepa | Thiotepa | Gland Pharma Limited | ANDA | Current |