Orange Book product · Generic (ANDA)
GEMFIBROZIL
GEMFIBROZIL
At a glance
Aug 16, 2010
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 16, 2010
16 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
GEMFIBROZIL
Strength
600MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 078599
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of GEMFIBROZIL
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ANDA 202726 · AUROBINDO PHARMA LTD
- 2010GEMFIBROZILGeneric (ANDA)
ANDA 079072 · NORTHSTAR HLTHCARE
- 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.
