FDA — authorised 24 January 2018
- Application: NDA022219
- Marketing authorisation holder: ENDO OPERATIONS
- Indication: Labeling
- Status: approved
🇺🇸 Tlando in United States
FDA authorised Tlando on 24 January 2018
Marketing authorisations
FDA — authorised 11 July 2025
- Application: NDA208088
- Marketing authorisation holder: VERITY
- Indication: Labeling
- Status: approved
The FDA approved Tlando, a drug for labeling indication, on July 11, 2025. The marketing authorization was granted to VERITY, the local brand name is not reported. This approval was made under the standard expedited pathway.
FDA — authorised 11 July 2025
- Application: NDA213953
- Marketing authorisation holder: MARIUS
- Indication: Labeling
- Status: approved
The FDA approved Tlando, a drug for labeling indication, on July 11, 2025. The marketing authorization was granted to MARIUS, the local marketing authorisation holder. The approval was made through the standard expedited pathway.
FDA — authorised 12 September 2025
- Application: NDA206089
- Marketing authorisation holder: TOLMAR
- Indication: Labeling
- Status: approved
The FDA approved Tlando, a drug developed by TOLMAR, for its approved indication on 12 September 2025. The application number for this approval is NDA206089. Tlando was granted marketing authorisation through a standard expedited pathway.
FDA
- Marketing authorisation holder: TOLMAR
- Status: approved
Tlando in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Tlando approved in United States?
Yes. FDA authorised it on 24 January 2018; FDA authorised it on 11 July 2025; FDA authorised it on 11 July 2025.
Who is the marketing authorisation holder for Tlando in United States?
ENDO OPERATIONS holds the US marketing authorisation.