FDA — authorised 22 October 1980
- Application: ANDA085128
- Marketing authorisation holder: TEVA
- Local brand name: ADIPEX-P
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Phentermine / Topiramate Oral Product in United States
FDA authorised Phentermine / Topiramate Oral Product on 22 October 1980
Marketing authorisations
FDA — authorised 2 August 1983
- Application: ANDA088023
- Marketing authorisation holder: TEVA
- Local brand name: ADIPEX-P
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 13 June 2011
- Application: NDA202088
- Marketing authorisation holder: CITIUS PHARMS
- Local brand name: SUPRENZA
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 16 August 2013
- Application: NDA201635
- Marketing authorisation holder: SUPERNUS PHARMS
- Local brand name: TROKENDI XR
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
Other Obesity / Weight Management approved in United States
Frequently asked questions
Is Phentermine / Topiramate Oral Product approved in United States?
Yes. FDA authorised it on 22 October 1980; FDA authorised it on 2 August 1983; FDA authorised it on 13 June 2011.
Who is the marketing authorisation holder for Phentermine / Topiramate Oral Product in United States?
TEVA holds the US marketing authorisation.