FDA — authorised 26 July 1993
- Application: ANDA063295
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: MONOCID
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Monocid in United States
FDA authorised Monocid on 26 July 1993
Marketing authorisations
FDA
- Status: approved
FDA
- Application: NDA050579
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: MONOCID
- Indication: INJECTABLE — INJECTION
- Status: approved
Monocid 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 Monocid approved in United States?
Yes. FDA authorised it on 26 July 1993; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for Monocid in United States?
GLAXOSMITHKLINE holds the US marketing authorisation.