Orange Book product · Generic (ANDA)
SULFASALAZINE
SULFASALAZINE
At a glance
Nov 04, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 04, 2025
8 mo ago
Today
Pharmaceutical detail
Active ingredient
SULFASALAZINE
Strength
500MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 219046
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of SULFASALAZINE
- 1983AZULFIDINE EN-TABSBrand (NDA)
NDA 007073 · PFIZER
- —AZULFIDINEBrand (NDA)
NDA 018605 · PHARMACIA AND UPJOHN
- 2002SULFASALAZINEGeneric (ANDA)
ANDA 075339 · NUVO PHARMS INC
- 2002SULFASALAZINEGeneric (ANDA)
ANDA 040349 · NUVO PHARMS INC
- 1987SULFASALAZINEGeneric (ANDA)
ANDA 089339 · SUPERPHARM
- 1987SULFASALAZINEGeneric (ANDA)
ANDA 089590 · SUN PHARM INDUSTRIES
- 1983SULFASALAZINEGeneric (ANDA)
ANDA 088052 · WATSON LABS
- —S.A.S.-500Generic (ANDA)
ANDA 083450 · SOLVAY
- —SULFASALAZINEGeneric (ANDA)
ANDA 080197 · CHARTWELL
- —SULFASALAZINEGeneric (ANDA)
ANDA 086184 · EPIC PHARMA LLC
- —SULFASALAZINEGeneric (ANDA)
ANDA 084964 · WATSON LABS
- —SULFASALAZINEGeneric (ANDA)
ANDA 085828 · WATSON LABS
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.
