FDA — authorised 8 March 1950
- Application: NDA007320
- Marketing authorisation holder: CONSOLIDATED MIDLAND
- Local brand name: TEEBACIN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Apacil in United States
FDA authorised Apacil on 8 March 1950
Marketing authorisations
FDA — authorised 14 April 1971
- Application: ANDA080097
- Marketing authorisation holder: HEXCEL
- Local brand name: SODIUM AMINOSALICYLATE
- Indication: POWDER — ORAL
- Status: approved
FDA — authorised 12 August 1975
- Application: ANDA080059
- Marketing authorisation holder: MEDPOINTE PHARM HLC
- Local brand name: NEOPASALATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 January 1978
- Application: ANDA080138
- Marketing authorisation holder: LANNETT
- Local brand name: SODIUM P.A.S.
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA006811
- Marketing authorisation holder: PANRAY
- Local brand name: PARASAL SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA080947
- Marketing authorisation holder: CENTURY PHARMS
- Local brand name: P.A.S. SODIUM
- Indication: POWDER — ORAL
- Status: approved
FDA
- 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 8 March 1950; FDA authorised it on 14 April 1971; FDA authorised it on 12 August 1975.
Who is the marketing authorisation holder for Apacil in United States?
CONSOLIDATED MIDLAND holds the US marketing authorisation.