Last Updated: September 24, 2026

Details for New Drug Application (NDA): 208791

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NDA 208791 describes CLOROTEKAL, which is a drug marketed by B Braun Medical and is included in one NDA. There are two patents protecting this drug. Additional details are available on the CLOROTEKAL profile page.

The generic ingredient in CLOROTEKAL is chloroprocaine hydrochloride. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the chloroprocaine hydrochloride profile page.

Summary for 208791

Tradename:	CLOROTEKAL
Applicant:	B Braun Medical
Ingredient:	chloroprocaine hydrochloride
Patents:	2

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRATHECAL			Strength	50MG/5ML (10MG/ML)
Approval Date:	Sep 26, 2017	TE:		RLD:	Yes
Patent:	⤷ Start Trial	Patent Expiration:	Sep 5, 2026	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	A METHOD FOR INDUCING A REGIONAL ANAESTHESIA VIA INTRATHECAL ADMINISTRATION OF A PATENTED PRESERVATIVE FREE SOLUTION FOR INJECTION (WITH A SPECIFIC COMPOSITION, PH, OSMOLALITY AND DENSITY) CONTAINING 9-11 MG/ML CHLOROPROCAINE HCL
Patent:	⤷ Start Trial	Patent Expiration:	Dec 11, 2033	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 208791

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
B Braun Medical	CLOROTEKAL	chloroprocaine hydrochloride	SOLUTION;INTRATHECAL	208791-001	Sep 26, 2017	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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