FDA — authorised 30 June 1994
- Application: ANDA074346
- Marketing authorisation holder: ADAPTIS
- Local brand name: PASER
- Indication: GRANULE, DELAYED RELEASE — ORAL
- Status: approved
🇺🇸 Apacil in United States
FDA authorised Apacil on 30 June 1994
Marketing authorisations
FDA
- Status: approved
FDA
- Application: NDA006811
- Marketing authorisation holder: PANRAY
- Local brand name: PARASAL
- Indication: TABLET — ORAL
- Status: approved
Apacil 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 Apacil approved in United States?
Yes. FDA authorised it on 30 June 1994; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for Apacil in United States?
ADAPTIS holds the US marketing authorisation.