FDA — authorised 5 October 1981
- Application: NDA018200
- Marketing authorisation holder: PADAGIS US
- Local brand name: MIDAMOR
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Midamor in United States
FDA authorised Midamor on 5 October 1981
Marketing authorisations
FDA — authorised 22 January 1986
- Application: ANDA070346
- Marketing authorisation holder: PH HEALTH
- Status: approved
FDA — authorised 14 April 1993
- Application: ANDA071111
- Marketing authorisation holder: BARR
- Indication: Labeling
- Status: approved
FDA — authorised 30 January 2009
- Application: ANDA079133
- Marketing authorisation holder: SIGMAPHARM LABS LLC
- Status: approved
Midamor in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Midamor approved in United States?
Yes. FDA authorised it on 5 October 1981; FDA authorised it on 22 January 1986; FDA authorised it on 14 April 1993.
Who is the marketing authorisation holder for Midamor in United States?
PADAGIS US holds the US marketing authorisation.