FDA — authorised 31 December 1986
- Application: NDA050608
- Marketing authorisation holder: PFIZER
- Local brand name: UNASYN
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Ampicillin / sulbactam in United States
FDA authorised Ampicillin / sulbactam on 31 December 1986
Marketing authorisations
FDA — authorised 25 November 1988
- Application: ANDA062901
- Marketing authorisation holder: PFIZER
- Local brand name: UNASYN
- Indication: INJECTABLE — INJECTION
- Status: approved
Other Infectious Disease approved in United States
Frequently asked questions
Is Ampicillin / sulbactam approved in United States?
Yes. FDA authorised it on 31 December 1986; FDA authorised it on 25 November 1988.
Who is the marketing authorisation holder for Ampicillin / sulbactam in United States?
PFIZER holds the US marketing authorisation.