Details for New Drug Application (NDA): 016949

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NDA 016949 describes LIMBITROL DS, which is a drug marketed by Chartwell Rx and is included in one NDA. Additional details are available on the LIMBITROL DS profile page.

The generic ingredient in LIMBITROL DS is amitriptyline hydrochloride; chlordiazepoxide. There are thirteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the amitriptyline hydrochloride; chlordiazepoxide profile page.

Summary for 016949

Tradename:	LIMBITROL DS
Applicant:	Chartwell Rx
Ingredient:	amitriptyline hydrochloride; chlordiazepoxide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 12.5MG BASE;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 25MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Expired US Patents for NDA 016949

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chartwell Rx	LIMBITROL	amitriptyline hydrochloride; chlordiazepoxide	TABLET;ORAL	016949-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Chartwell Rx	LIMBITROL DS	amitriptyline hydrochloride; chlordiazepoxide	TABLET;ORAL	016949-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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