FDA — authorised 8 February 1967
- Status: approved
🇺🇸 Lipavil in United States
FDA authorised Lipavil on 8 February 1967
Marketing authorisations
FDA — authorised 16 June 1986
- Application: ANDA070531
- Marketing authorisation holder: USL PHARMA
- Local brand name: CLOFIBRATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 July 1991
- Application: ANDA072600
- Marketing authorisation holder: TEVA
- Local brand name: CLOFIBRATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 20 March 1992
- Application: ANDA073396
- Marketing authorisation holder: BANNER PHARMACAPS
- Local brand name: CLOFIBRATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA072191
- Marketing authorisation holder: SANDOZ
- Local brand name: CLOFIBRATE
- Indication: CAPSULE — ORAL
- Status: approved
Lipavil 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 Lipavil approved in United States?
Yes. FDA authorised it on 8 February 1967; FDA authorised it on 16 June 1986; FDA authorised it on 25 July 1991.
Who is the marketing authorisation holder for Lipavil in United States?
Marketing authorisation holder not available in our data.