Orange Book product · Brand (NDA)
AZULFIDINE
SULFASALAZINE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
SULFASALAZINE
Strength
250MG/5ML
Dosage form
SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 018605
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 1983AZULFIDINE EN-TABSBrand (NDA)
NDA 007073 · PFIZER
- 2025SULFASALAZINEGeneric (ANDA)
ANDA 219046 · RISING
- 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.
