FDA — authorised 29 July 1974
- Status: approved
🇺🇸 Salagen in United States
FDA authorised Salagen on 29 July 1974
Marketing authorisations
FDA — authorised 29 July 1974
- Application: NDA017431
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: OCUSERT PILO-20
- Indication: INSERT, EXTENDED RELEASE — OPHTHALMIC
- Status: approved
FDA — authorised 29 July 1974
- Application: NDA017548
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: OCUSERT PILO-40
- Indication: INSERT, EXTENDED RELEASE — OPHTHALMIC
- Status: approved
FDA — authorised 22 March 1994
- Application: NDA020237
- Marketing authorisation holder: ADVANZ PHARMA
- Local brand name: SALAGEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 March 2006
- Application: ANDA077248
- Marketing authorisation holder: IMPAX LABS
- Status: approved
FDA — authorised 27 February 2007
- Application: ANDA076963
- Marketing authorisation holder: INNOGENIX
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 6 May 2009
- Application: ANDA077220
- Marketing authorisation holder: LANNETT CO INC
- Indication: Labeling
- Status: approved
FDA — authorised 28 April 2025
- Application: ANDA217733
- Marketing authorisation holder: AMNEAL
- Status: approved
Salagen 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 Salagen approved in United States?
Yes. FDA authorised it on 29 July 1974; FDA authorised it on 29 July 1974; FDA authorised it on 29 July 1974.
Who is the marketing authorisation holder for Salagen in United States?
Marketing authorisation holder not available in our data.