FDA — authorised 20 January 2015
- Application: NDA022370
- Marketing authorisation holder: CIPHER PHARMS INC
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Ultram in United States
FDA authorised Ultram on 20 January 2015
Marketing authorisations
FDA — authorised 11 May 2020
- Application: ANDA211825
- Marketing authorisation holder: UNICHEM
- Indication: Labeling
- Status: approved
FDA — authorised 7 December 2023
- Application: ANDA075977
- Marketing authorisation holder: TEVA
- Indication: Labeling
- Status: approved
FDA — authorised 2 August 2024
- Application: ANDA075968
- Marketing authorisation holder: GRAVITI PHARMS
- Indication: Manufacturing (CMC)
- Status: approved
The FDA approved the manufacturing (CMC) indication for Ultram, a pharmaceutical product, on 2024-08-02. This approval was granted to GRAVITI PHARMS under application number ANDA075968. The approval follows a standard review process.
FDA — authorised 29 December 2025
- Application: ANDA091607
- Marketing authorisation holder: SUN PHARM
- Indication: Labeling
- Status: approved
SUN PHARM was granted marketing authorisation by the FDA for Ultram on 2025-12-29. The approval was based on a standard expedited pathway. The approved indication for Ultram is listed in the labelling.
Ultram in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Pain approved in United States
Frequently asked questions
Is Ultram approved in United States?
Yes. FDA authorised it on 20 January 2015; FDA authorised it on 11 May 2020; FDA authorised it on 7 December 2023.
Who is the marketing authorisation holder for Ultram in United States?
CIPHER PHARMS INC holds the US marketing authorisation.