FDA — authorised 5 June 1970
- Application: NDA016620
- Marketing authorisation holder: ALMATICA
- Local brand name: MACRODANTIN
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 MACRODANTIN in United States
FDA authorised MACRODANTIN on 5 June 1970
Marketing authorisations
FDA
- Status: approved
MACRODANTIN 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 MACRODANTIN approved in United States?
Yes. FDA authorised it on 5 June 1970; FDA has authorised it.
Who is the marketing authorisation holder for MACRODANTIN in United States?
ALMATICA holds the US marketing authorisation.