FDA — authorised 3 December 1954
- Marketing authorisation holder: VALEANT PHARM INTL
- Status: approved
🇺🇸 Oxsoralen-Ultra in United States
FDA authorised Oxsoralen-Ultra on 3 December 1954
Marketing authorisations
FDA — authorised 3 December 1954
- Application: NDA009048
- Marketing authorisation holder: VALEANT PHARM INTL
- Local brand name: OXSORALEN
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 30 October 1986
- Application: NDA019600
- Marketing authorisation holder: BAUSCH
- Local brand name: OXSORALEN-ULTRA
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 November 2013
- Application: NDA020969
- Marketing authorisation holder: THERAKOS DEVELOPMENT
- Indication: Labeling
- Status: approved
FDA — authorised 5 June 2014
- Application: ANDA202687
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Local brand name: METHOXSALEN
- Indication: CAPSULE — ORAL
- Status: approved
ONESOURCE SPECIALTY received marketing authorisation from the FDA for Oxsoralen-Ultra on 8 January 2024. The application number for this approval is ANDA202687. The indication approved for Oxsoralen-Ultra is listed in the labelling, but the specific indication is not reported. This approval was granted through the standard expedited pathway.
FDA — authorised 9 June 2015
- Application: ANDA202603
- Marketing authorisation holder: ACTAVIS INC
- Local brand name: METHOXSALEN
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA087781
- Marketing authorisation holder: ANI PHARMS
- Local brand name: METHOXSALEN
- Indication: CAPSULE — ORAL
- Status: approved
Oxsoralen-Ultra 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 Oxsoralen-Ultra approved in United States?
Yes. FDA authorised it on 3 December 1954; FDA authorised it on 3 December 1954; FDA authorised it on 30 October 1986.
Who is the marketing authorisation holder for Oxsoralen-Ultra in United States?
VALEANT PHARM INTL holds the US marketing authorisation.