Details for New Drug Application (NDA): 216984
NDA 216984 describes TEPYLUTE, which is a drug marketed by Shorla and is included in one NDA. There are two patents protecting this drug. Additional details are available on the TEPYLUTE profile page.
The generic ingredient in TEPYLUTE is thiotepa. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the thiotepa profile page.
The generic ingredient in TEPYLUTE is thiotepa. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the thiotepa profile page.
Medical Subject Heading (MeSH) Categories for 216984
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 15MG/1.5ML (10MG/ML) | ||||
| Approval Date: | Jun 25, 2024 | TE: | RLD: | Yes | |||||
| Patent: | 11,975,013 | Patent Expiration: | Aug 16, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 12,622,921 | Patent Expiration: | Aug 16, 2041 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ADENOCARCINOMA OF THE BREAST OR OVARY | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 100MG/10ML (10MG/ML) | ||||
| Approval Date: | Feb 26, 2025 | TE: | RLD: | Yes | |||||
| Patent: | 11,975,013 | Patent Expiration: | Aug 16, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Complete Access Available with Subscription
