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Chubb
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Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090896

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NDA 090896 describes CHLOROTHIAZIDE SODIUM, which is a drug marketed by Fresenius Kabi Usa, Luitpold, Mylan Institutional, Sagent Pharms, and Sun Pharma Global, and is included in five NDAs. It is available from four suppliers. Additional details are available on the CHLOROTHIAZIDE SODIUM profile page.

The generic ingredient in CHLOROTHIAZIDE SODIUM is chlorothiazide sodium. There are forty-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the chlorothiazide sodium profile page.
Summary for 090896
Tradename:CHLOROTHIAZIDE SODIUM
Applicant:Fresenius Kabi Usa
Ingredient:chlorothiazide sodium
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090896
Ingredient-typeThiazides
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 090896
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHLOROTHIAZIDE SODIUM chlorothiazide sodium INJECTABLE;INJECTION 090896 ANDA Fresenius Kabi USA, LLC 63323-658 N 63323-658-20
CHLOROTHIAZIDE SODIUM chlorothiazide sodium INJECTABLE;INJECTION 090896 ANDA Fresenius Kabi USA, LLC 63323-658 N 63323-658-27

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Oct 16, 2009TE:APRLD:No

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