FDA — authorised 23 October 1956
- Application: NDA010571
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: COMPAZINE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Compazine in United States
FDA authorised Compazine on 23 October 1956
Marketing authorisations
FDA — authorised 23 October 1956
- Marketing authorisation holder: GLAXOSMITHKLINE
- Status: approved
FDA — authorised 10 December 1957
- Application: NDA011188
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: COMPAZINE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 26 January 1959
- Application: NDA011127
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: COMPAZINE
- Indication: SUPPOSITORY — RECTAL
- Status: approved
FDA — authorised 8 June 1982
- Application: ANDA087153
- Marketing authorisation holder: ALPHARMA US PHARMS
- Local brand name: PROCHLORPERAZINE
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA — authorised 1 October 1982
- Application: ANDA087759
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: PROCHLORPERAZINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 November 1993
- Application: ANDA040058
- Marketing authorisation holder: COSETTE
- Local brand name: PROCHLORPERAZINE
- Indication: SUPPOSITORY — RECTAL
- Status: approved
FDA — authorised 6 October 1999
- Application: NDA021019
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: COMPAZINE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 11 July 2001
- Application: ANDA040407
- Marketing authorisation holder: ABLE
- Local brand name: PROCHLORPERAZINE
- Indication: SUPPOSITORY — RECTAL
- Status: approved
FDA
- Application: ANDA085178
- Marketing authorisation holder: WATSON LABS
- Local brand name: PROCHLORPERAZINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085579
- Marketing authorisation holder: WATSON LABS
- Local brand name: PROCHLORPERAZINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085580
- Marketing authorisation holder: WATSON LABS
- Local brand name: PROCHLORPERAZINE
- Indication: TABLET — ORAL
- Status: approved
Compazine in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Compazine approved in United States?
Yes. FDA authorised it on 23 October 1956; FDA authorised it on 23 October 1956; FDA authorised it on 10 December 1957.
Who is the marketing authorisation holder for Compazine in United States?
GLAXOSMITHKLINE holds the US marketing authorisation.