Chlorothiazide sodium - Generic Drug Details

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What are the generic drug sources for chlorothiazide sodium and what is the scope of patent protection?

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

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

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

Sponsor

Phase

Vanderbilt University

Phase 4

National Heart, Lung, and Blood Institute (NHLBI)

Phase 1

Yale University

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
Am Regent	CHLOROTHIAZIDE SODIUM	chlorothiazide sodium	INJECTABLE;INJECTION	202561-001	Apr 22, 2013	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Rising	DIURIL	chlorothiazide sodium	INJECTABLE;INJECTION	011145-005	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm	CHLOROTHIAZIDE SODIUM	chlorothiazide sodium	INJECTABLE;INJECTION	091546-001	Jul 26, 2011	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi Usa	CHLOROTHIAZIDE SODIUM	chlorothiazide sodium	INJECTABLE;INJECTION	090896-001	Oct 16, 2009	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sagent Pharms Inc	CHLOROTHIAZIDE SODIUM	chlorothiazide sodium	INJECTABLE;INJECTION	202462-001	May 29, 2015	AP	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Rk Pharma	CHLOROTHIAZIDE SODIUM	chlorothiazide sodium	INJECTABLE;INJECTION	202493-001	Jun 18, 2014	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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:	6
NDAs:	6
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	9
Clinical Trials:	4
Patent Applications:	25
Formulation / Manufacturing:	see details
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