Viewing data from:

Not in the current Orange Book — This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.

AZULFIDINE EN-TABS

NDANot in Orange Book

SULFASALAZINE | N021243 | PHARMACIA UPJOHN

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain3 active DMFs6 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

CAMBREX CHARLES CITY INCSULFASALAZINE USP

DMF 22391974

VALENS MOLECULES PRIVATE LTDSULFASALAZINE USP

DMF 261272012

CAMBREX CHARLES CITY INCSULFASALAZINE, PURIFIED

DMF 419262025

ACF CHEMIEFARMA NVInactiveSULFASALAZINE

DMF 64891986

IFP INCInactiveSULFASALAZINE STARCH POWDER

DMF 71271987

CORDEN PHARMA BERGAMO SPAInactiveSULFASALAZINE

DMF 111631994

SALSBURY CHEMICALS INCInactiveSULFASALAZINE PVP

DMF 146882000

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTDInactiveSULFASALAZINE

DMF 147242000

SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO LTDInactiveSULFASALAZINE

DMF 222382008

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 17, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 500MG

▴

TABLET; ORAL | Approved: Aug. 18, 2000

No patent or exclusivity listings for this strength.