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Last Updated: July 7, 2020

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Details for New Drug Application (NDA): 011145


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NDA 011145 describes DIURIL, which is a drug marketed by Oak Pharms Akorn and Salix Pharms and is included in two NDAs. It is available from two 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. Three suppliers are listed for this compound. Additional details are available on the chlorothiazide profile page.
Summary for 011145
Tradename:DIURIL
Applicant:Oak Pharms Akorn
Ingredient:chlorothiazide
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 011145
Suppliers and Packaging for NDA: 011145
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIURIL chlorothiazide sodium INJECTABLE;INJECTION 011145 NDA AUTHORIZED GENERIC Akorn, Inc. 17478-419 17478-419-40 1 VIAL in 1 CARTON (17478-419-40) > 1 INJECTION in 1 VIAL
DIURIL chlorothiazide TABLET;ORAL 011145 NDA AUTHORIZED GENERIC Akorn, Inc. 17478-419 17478-419-40 1 VIAL in 1 CARTON (17478-419-40) > 1 INJECTION in 1 VIAL

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 005

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

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