Orange Book product · Generic (ANDA)
DIFLUNISAL
DIFLUNISAL
At a glance
Jun 16, 2017
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 16, 2017
9 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
DIFLUNISAL
Strength
500MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 203547
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DIFLUNISAL
- 1982DOLOBIDBrand (NDA)
NDA 018445 · MERCK
- 2024DIFLUNISALGeneric (ANDA)
ANDA 202845 · HERITAGE PHARMA
- 1997DIFLUNISALGeneric (ANDA)
ANDA 074400 · WATSON LABS
- 1996DIFLUNISALGeneric (ANDA)
ANDA 074604 · ANI PHARMS
- 1996DIFLUNISALGeneric (ANDA)
ANDA 074285 · PUREPAC PHARM
- 1992DIFLUNISALGeneric (ANDA)
ANDA 073562 · DASTECH INTL
- 1992DIFLUNISALGeneric (ANDA)
ANDA 073563 · DASTECH INTL
- 1992DIFLUNISALGeneric (ANDA)
ANDA 073679 · TEVA
- 1992DIFLUNISALGeneric (ANDA)
ANDA 073673 · TEVA
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.
