Orange Book product · Brand (NDA)
DOLOBID
DIFLUNISAL
At a glance
Apr 19, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 19, 1982
44 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
DIFLUNISAL
Strength
250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 018445
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2024DIFLUNISALGeneric (ANDA)
ANDA 202845 · HERITAGE PHARMA
- 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.
