Details for New Drug Application (NDA): 019807

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NDA 019807 describes KERLEDEX, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. Additional details are available on the KERLEDEX profile page.

The generic ingredient in KERLEDEX is betaxolol hydrochloride; chlorthalidone. There are eleven drug master file entries for this compound. Additional details are available on the betaxolol hydrochloride; chlorthalidone profile page.

Summary for 019807

Tradename:	KERLEDEX
Applicant:	Sanofi Aventis Us
Ingredient:	betaxolol hydrochloride; chlorthalidone
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG;12.5MG
Approval Date:	Oct 30, 1992	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG;12.5MG
Approval Date:	Oct 30, 1992	TE:		RLD:	No

Expired US Patents for NDA 019807

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	KERLEDEX	betaxolol hydrochloride; chlorthalidone	TABLET;ORAL	019807-001	Oct 30, 1992	⤷ Subscribe	⤷ Subscribe
Sanofi Aventis Us	KERLEDEX	betaxolol hydrochloride; chlorthalidone	TABLET;ORAL	019807-002	Oct 30, 1992	⤷ Subscribe	⤷ Subscribe
Sanofi Aventis Us	KERLEDEX	betaxolol hydrochloride; chlorthalidone	TABLET;ORAL	019807-001	Oct 30, 1992	⤷ Subscribe	⤷ Subscribe
Sanofi Aventis Us	KERLEDEX	betaxolol hydrochloride; chlorthalidone	TABLET;ORAL	019807-002	Oct 30, 1992	⤷ Subscribe	⤷ Subscribe
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