FDA — authorised 7 April 1948
- Marketing authorisation holder: SANOFI AVENTIS US
- Status: approved
🇺🇸 Unisom in United States
FDA authorised Unisom on 7 April 1948
Marketing authorisations
FDA — authorised 10 February 1998
- Application: ANDA040167
- Marketing authorisation holder: PERRIGO
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 27 August 2004
- Application: ANDA040564
- Marketing authorisation holder: LNK
- Status: approved
FDA — authorised 6 December 2017
- Application: ANDA208518
- Marketing authorisation holder: PH HEALTH
- Status: approved
FDA — authorised 24 February 2020
- Application: ANDA205811
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Indication: Labeling
- Status: approved
FDA — authorised 6 July 2020
- Application: ANDA207825
- Marketing authorisation holder: PHARMOBEDIENT
- Status: approved
FDA
- Application: NDA019440
- Marketing authorisation holder: PFIZER
- Local brand name: UNISOM
- Indication: CAPSULE — ORAL
- Status: approved
Unisom in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Unisom approved in United States?
Yes. FDA authorised it on 7 April 1948; FDA authorised it on 10 February 1998; FDA authorised it on 27 August 2004.
Who is the marketing authorisation holder for Unisom in United States?
SANOFI AVENTIS US holds the US marketing authorisation.