FDA — authorised 31 December 1943
- Marketing authorisation holder: RECORDATI RARE
- Status: approved
🇺🇸 Desoxyn in United States
FDA authorised Desoxyn on 31 December 1943
Marketing authorisations
FDA — authorised 2 September 2016
- Application: ANDA091189
- Marketing authorisation holder: DR REDDYS LABS SA
- Indication: Labeling
- Status: approved
FDA — authorised 18 April 2024
- Application: ANDA203846
- Marketing authorisation holder: HIKMA
- Indication: Labeling
- Status: approved
The FDA approved Desoxyn, a medication, for its labelled indication on 18 April 2024. The marketing authorisation was granted to HIKMA, the marketing authorisation holder. This approval was made under the standard expedited pathway.
Desoxyn in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Desoxyn approved in United States?
Yes. FDA authorised it on 31 December 1943; FDA authorised it on 2 September 2016; FDA authorised it on 18 April 2024.
Who is the marketing authorisation holder for Desoxyn in United States?
RECORDATI RARE holds the US marketing authorisation.