Orange Book product · Generic (ANDA)
DIFLUNISAL
DIFLUNISAL
At a glance
Aug 16, 2024
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 16, 2024
1 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
DIFLUNISAL
Strength
250MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 202845
Product number
002
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
- 2017DIFLUNISALGeneric (ANDA)
ANDA 203547 · ZYDUS PHARMS
- 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.
