Orange Book product · Brand (NDA)
AZULFIDINE EN-TABS
SULFASALAZINE
At a glance
Apr 06, 1983
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 06, 1983
43 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
SULFASALAZINE
Strength
500MG
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
TE code
AB
Application
NDA 007073
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- —AZULFIDINEBrand (NDA)
NDA 018605 · PHARMACIA AND UPJOHN
- 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.
