FDA — authorised 21 December 1981
- Application: NDA018422
- Marketing authorisation holder: PFIZER PHARMS
- Local brand name: LOPID
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Lopid in United States
FDA authorised Lopid on 21 December 1981
Marketing authorisations
FDA — authorised 25 January 1993
- Application: ANDA073466
- Marketing authorisation holder: NATCO
- Local brand name: GEMFIBROZIL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 September 1993
- Application: ANDA074270
- Marketing authorisation holder: CHARTWELL MOLECULES
- Local brand name: GEMFIBROZIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 October 1993
- Application: ANDA074256
- Marketing authorisation holder: TEVA
- Local brand name: GEMFIBROZIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 September 1995
- Application: ANDA074615
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: GEMFIBROZIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 March 2007
- Application: ANDA078012
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: GEMFIBROZIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 December 2008
- Application: ANDA079239
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: GEMFIBROZIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 August 2010
- Application: ANDA078599
- Marketing authorisation holder: HIKMA PHARMS
- Local brand name: GEMFIBROZIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 September 2015
- Application: ANDA079072
- Marketing authorisation holder: NORTHSTAR HLTHCARE
- Indication: Labeling
- Status: approved
FDA — authorised 17 June 2016
- Application: ANDA203266
- Marketing authorisation holder: CADILA PHARMS LTD
- Local brand name: GEMFIBROZIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 September 2017
- Application: ANDA202726
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Indication: Labeling
- Status: approved
FDA — authorised 28 August 2018
- Application: ANDA204189
- Marketing authorisation holder: CADILA
- Status: approved
FDA — authorised 13 January 2021
- Application: ANDA214603
- Marketing authorisation holder: ASCENT PHARMS INC
- Status: approved
FDA — authorised 17 August 2022
- Application: ANDA077836
- Marketing authorisation holder: INVAGEN PHARMS
- Indication: Labeling
- Status: approved
FDA
- Application: ANDA074360
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: GEMFIBROZIL
- Indication: TABLET — ORAL
- Status: approved
Lopid 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 Lopid approved in United States?
Yes. FDA authorised it on 21 December 1981; FDA authorised it on 25 January 1993; FDA authorised it on 27 September 1993.
Who is the marketing authorisation holder for Lopid in United States?
PFIZER PHARMS holds the US marketing authorisation.