CHLOROTHIAZIDE SODIUM - Generic Drug Details

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What are the generic sources for chlorothiazide sodium and what is the scope of freedom to operate?

Chlorothiazide sodium is the generic ingredient in two branded drugs marketed by Am Regent, Fresenius Kabi Usa, Gland Pharma Ltd, Rk Pharma, Sagent Pharms Inc, Sun Pharm, and Rising, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for chlorothiazide sodium. Five suppliers are listed for this compound.

Sponsor	Phase
Vanderbilt University	Phase 4
Yale University	Phase 1
National Heart, Lung, and Blood Institute (NHLBI)	Phase 1

Sponsor

Phase

Vanderbilt University

Phase 4

Yale University

Phase 1

National Heart, Lung, and Blood Institute (NHLBI)

Phase 1

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rk Pharma	CHLOROTHIAZIDE SODIUM	chlorothiazide sodium	INJECTABLE;INJECTION	202493-001	Jun 18, 2014		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm	CHLOROTHIAZIDE SODIUM	chlorothiazide sodium	INJECTABLE;INJECTION	091546-001	Jul 26, 2011	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	CHLOROTHIAZIDE SODIUM	chlorothiazide sodium	INJECTABLE;INJECTION	090896-001	Oct 16, 2009	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Gland Pharma Ltd	CHLOROTHIAZIDE SODIUM	chlorothiazide sodium	INJECTABLE;INJECTION	218630-001	Oct 3, 2024	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Am Regent	CHLOROTHIAZIDE SODIUM	chlorothiazide sodium	INJECTABLE;INJECTION	202561-001	Apr 22, 2013	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	7
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	9
Clinical Trials:	4
Patent Applications:	24
What excipients (inactive ingredients) are in CHLOROTHIAZIDE SODIUM?	CHLOROTHIAZIDE SODIUM excipients list
DailyMed Link:	CHLOROTHIAZIDE SODIUM at DailyMed

Drug Class	Thiazide Diuretic
Physiological Effect	Increased Diuresis