BETHANECHOL CHLORIDE - Generic Drug Details

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What are the generic drug sources for bethanechol chloride and what is the scope of freedom to operate?

Bethanechol chloride is the generic ingredient in four branded drugs marketed by Odyssey Pharms, Able, Actavis Elizabeth, Amneal Pharm, Ascot, Chartwell Rx, Heritage Pharma, Impax Labs, Ivax Sub Teva Pharms, Lannett, Lannett Co Inc, Sandoz, Sun Pharm Inds Inc, Upsher Smith Labs, Watson Labs, Wockhardt, and Glenwood, and is included in fifty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for bethanechol chloride. Seven suppliers are listed for this compound.

Sponsor	Phase
Rajavithi Hospital	Phase 4

Sponsor

Phase

Rajavithi Hospital

Phase 4

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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
Odyssey Pharms	URECHOLINE	bethanechol chloride	TABLET;ORAL	006536-005	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharm	BETHANECHOL CHLORIDE	bethanechol chloride	TABLET;ORAL	040855-002	Nov 21, 2007	AA	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Upsher Smith Labs	BETHANECHOL CHLORIDE	bethanechol chloride	TABLET;ORAL	040634-001	Jun 1, 2005	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz	BETHANECHOL CHLORIDE	bethanechol chloride	TABLET;ORAL	084379-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glenwood	MYOTONACHOL	bethanechol chloride	TABLET;ORAL	084188-003	Approved Prior to Jan 1, 1982		DISCN	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:	4
Applicants:	17
NDAs:	53
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	1
Patent Applications:	2,109
What excipients (inactive ingredients) are in BETHANECHOL CHLORIDE?	BETHANECHOL CHLORIDE excipients list
DailyMed Link:	BETHANECHOL CHLORIDE at DailyMed

Drug Class	Cholinergic Muscarinic Agonist
Mechanism of Action	Cholinergic Muscarinic Agonists