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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 202561


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NDA 202561 describes CHLOROTHIAZIDE SODIUM, which is a drug marketed by Am Regent, Fresenius Kabi Usa, Rk Pharma, Sagent Pharms Inc, and Sun Pharm, 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. Four suppliers are listed for this compound. Additional details are available on the chlorothiazide sodium profile page.
Summary for 202561
Tradename:CHLOROTHIAZIDE SODIUM
Applicant:Am Regent
Ingredient:chlorothiazide sodium
Patents:0
Pharmacology for NDA: 202561
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 202561
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHLOROTHIAZIDE SODIUM chlorothiazide sodium INJECTABLE;INJECTION 202561 ANDA American Regent, Inc. 0517-1820 0517-1820-01 1 VIAL in 1 CARTON (0517-1820-01) / 18 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Apr 22, 2013TE:APRLD:No

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