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Generated: August 18, 2017

DrugPatentWatch Database Preview

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 three suppliers. Additional details are available on the DIURIL profile page.

The generic ingredient in DIURIL is chlorothiazide. There are forty-one drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the chlorothiazide profile page.

Summary for NDA: 011145

Tradename:
1
Applicant:
1
Ingredient:
2
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 011145

Ingredient-typeThiazides
Physiological EffectIncreased Diuresis

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

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Summary 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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