FDA — authorised 29 September 1986
- Application: NDA018731
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: BUSPAR
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Buspar in United States
FDA authorised Buspar on 29 September 1986
Marketing authorisations
FDA — authorised 20 December 2000
- Application: NDA021190
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: BUSPAR
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 June 2001
- Application: ANDA076008
- Marketing authorisation holder: MYLAN
- Status: approved
FDA — authorised 16 March 2008
- Application: ANDA075388
- Marketing authorisation holder: OXFORD PHARMS
- Indication: Labeling
- Status: approved
FDA — authorised 30 June 2015
- Application: ANDA202330
- Marketing authorisation holder: STRIDES PHARMA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 1 March 2019
- Application: ANDA204582
- Marketing authorisation holder: HERITAGE PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 6 October 2025
- Application: ANDA075413
- Marketing authorisation holder: RISING
- Indication: Manufacturing (CMC)
- Status: approved
The FDA approved Buspar for manufacturing (CMC) on 2025-10-06. This approval was granted to RISING under application number ANDA075413. The approval was processed through the standard expedited pathway.
Buspar 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 Buspar approved in United States?
Yes. FDA authorised it on 29 September 1986; FDA authorised it on 20 December 2000; FDA authorised it on 28 June 2001.
Who is the marketing authorisation holder for Buspar in United States?
BRISTOL MYERS SQUIBB holds the US marketing authorisation.