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Generated: November 20, 2018

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Details for New Drug Application (NDA): 011870

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NDA 011870 describes DIURIL, which is a drug marketed by Oak Pharms Akorn and Salix Pharms and is included in two NDAs. It is available from three suppliers. Additional details are available on the DIURIL profile page.

The generic ingredient in DIURIL is chlorothiazide. There are forty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the chlorothiazide profile page.
Summary for 011870
Applicant:Salix Pharms
Formulation / Manufacturing:see details
Pharmacology for NDA: 011870
Physiological EffectIncreased Diuresis
Medical Subject Heading (MeSH) Categories for 011870
Suppliers and Packaging for NDA: 011870
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIURIL chlorothiazide SUSPENSION;ORAL 011870 NDA Salix Pharmaceuticals, Inc 65649-311 65649-311-12 237 mL in 1 BOTTLE (65649-311-12)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength250MG/5ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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