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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 090896


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NDA 090896 describes CHLOROTHIAZIDE SODIUM, which is a drug marketed by Am Regent, Fresenius Kabi Usa, Gland Pharma Ltd, Rk Pharma, Sagent Pharms Inc, and Sun Pharm, and is included in six NDAs. It is available from five 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. Five 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
Pharmacology for NDA: 090896
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 63323-658-94 1 VIAL in 1 BOX (63323-658-94) / 18 mL in 1 VIAL
CHLOROTHIAZIDE SODIUM chlorothiazide sodium INJECTABLE;INJECTION 090896 ANDA Fresenius Kabi USA, LLC 63323-658 63323-658-27 1 VIAL in 1 BOX (63323-658-27) / 18 mL in 1 VIAL

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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