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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 202462

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NDA 202462 describes CHLOROTHIAZIDE SODIUM, which is a drug marketed by Am Regent, Fresenius Kabi Usa, Gland, 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 202462

Tradename:	CHLOROTHIAZIDE SODIUM
Applicant:	Sagent Pharms Inc
Ingredient:	chlorothiazide sodium
Patents:	0

Pharmacology for NDA: 202462

Physiological Effect	Increased Diuresis

Suppliers and Packaging for NDA: 202462

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHLOROTHIAZIDE SODIUM	chlorothiazide sodium	INJECTABLE;INJECTION	202462	ANDA	Sagent Pharmaceuticals	25021-305	25021-305-66	1 VIAL in 1 CARTON (25021-305-66) / 18 mL in 1 VIAL
CHLOROTHIAZIDE SODIUM	chlorothiazide sodium	INJECTABLE;INJECTION	202462	ANDA	Sagent Pharmaceuticals	25021-305	25021-305-20	1 VIAL in 1 CARTON (25021-305-20) / 18 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 500MG BASE/VIAL
Approval Date:	May 29, 2015	TE:	AP	RLD:	No

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