FDA — authorised 7 February 1979
- Application: NDA017862
- Marketing authorisation holder: HIKMA
- Local brand name: REGLAN
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Standard Care in United States
FDA authorised Standard Care on 7 February 1979
Marketing authorisations
FDA — authorised 30 December 1980
- Application: NDA017854
- Marketing authorisation holder: ANI PHARMS
- Local brand name: REGLAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 March 1983
- Application: NDA018821
- Marketing authorisation holder: ROBINS AH
- Local brand name: REGLAN
- Indication: SOLUTION — ORAL
- Status: approved
Frequently asked questions
Is Standard Care approved in United States?
Yes. FDA authorised it on 7 February 1979; FDA authorised it on 30 December 1980; FDA authorised it on 25 March 1983.
Who is the marketing authorisation holder for Standard Care in United States?
HIKMA holds the US marketing authorisation.