FDA — authorised 31 December 1986
- Marketing authorisation holder: PFIZER
- Status: approved
🇺🇸 Unasyn in United States
FDA authorised Unasyn on 31 December 1986
Marketing authorisations
FDA — authorised 5 August 2008
- Application: ANDA065188
- Marketing authorisation holder: HQ SPECLT PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 1 May 2015
- Application: ANDA065176
- Marketing authorisation holder: HQ SPECLT PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 19 April 2020
- Application: ANDA201024
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Indication: Labeling
- Status: approved
FDA — authorised 19 April 2020
- Application: ANDA090339
- Marketing authorisation holder: EUGIA PHARMA SPECLTS
- Indication: Labeling
- Status: approved
FDA — authorised 12 October 2022
- Application: ANDA090340
- Marketing authorisation holder: EUGIA PHARMA SPECLTS
- Indication: Labeling
- Status: approved
Unasyn in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Unasyn approved in United States?
Yes. FDA authorised it on 31 December 1986; FDA authorised it on 5 August 2008; FDA authorised it on 1 May 2015.
Who is the marketing authorisation holder for Unasyn in United States?
PFIZER holds the US marketing authorisation.