Orange Book product · Brand (NDA)
LOPID
GEMFIBROZIL
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
GEMFIBROZIL
Strength
300MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 018422
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 2021GEMFIBROZILGeneric (ANDA)
ANDA 214603 · ASCENT PHARMS INC
- 2018GEMFIBROZILGeneric (ANDA)
ANDA 204189 · CADILA
- 2016GEMFIBROZILGeneric (ANDA)
ANDA 203266 · CADILA PHARMS LTD
- 2015GEMFIBROZILGeneric (ANDA)
ANDA 202726 · AUROBINDO PHARMA LTD
- 2010GEMFIBROZILGeneric (ANDA)
ANDA 079072 · NORTHSTAR HLTHCARE
- 2010GEMFIBROZILGeneric (ANDA)
ANDA 078599 · HIKMA PHARMS
- 2008GEMFIBROZILGeneric (ANDA)
ANDA 079239 · SUN PHARM INDS INC
- 2007GEMFIBROZILGeneric (ANDA)
ANDA 078207 · IMPAX PHARMS
- 2007GEMFIBROZILGeneric (ANDA)
ANDA 078012 · EPIC PHARMA LLC
- 2006GEMFIBROZILGeneric (ANDA)
ANDA 077836 · INVAGEN PHARMS
- 1998GEMFIBROZILGeneric (ANDA)
ANDA 075034 · APOTEX
- 1995GEMFIBROZILGeneric (ANDA)
ANDA 074615 · CHARTWELL RX
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
