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DIURIL

NDA

CHLOROTHIAZIDE | N011870 | SALIX PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

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 Chain5 active DMFs5 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

CAMBREX PROFARMACO MILANO SRLCHLOROTHIAZIDE

DMF 8831965

SUN PHARMACEUTICAL INDUSTRIES LTDCHLOROTHIAZIDE USP

DMF 227302009

CTX LIFE SCIENCES PVT LTDCHLOROTHIAZIDE USP

DMF 230152009

G AND A ASSOC INCCHLOROTHIAZIDE USP, NON-STERILE, BULK DRUG

DMF 240842010

GLAND PHARMA LTDCHLOROTHIAZIDE

DMF 372272022

INDUSTRIA CHEMICA PRODOTTI FRANCIS SPAInactiveCHLOROTHIAZIDE (BULK) - HYDROCHLOROTHIAZIDE

DMF 4561961

NAPP CHEMICALS INCInactiveCHLOROTHIAZIDE

DMF 25271975

ACIC LTDInactiveCHLOROTHIAZIDE PROCEDURES FOR

DMF 43251981

PLIVA PHARMACEUTICAL CHEMICAL FOOD & COSMETIC INDUSTRYInactiveCHLOROTHIAZIDE

DMF 46101982

CHIFENG ARKER PHARMACEUTICAL TECHNOLOGY CO LTDInactiveCHLOROTHIAZIDE

DMF 220172008

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

Approval Letters

4 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 250MG/5ML

RLD

0 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.