Details for New Drug Application (NDA): 012703

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NDA 012703 describes ELAVIL, which is a drug marketed by Astrazeneca and is included in two NDAs. Additional details are available on the ELAVIL profile page.

The generic ingredient in ELAVIL is amitriptyline hydrochloride. There are thirteen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the amitriptyline hydrochloride profile page.

Summary for 012703

Tradename:	ELAVIL
Applicant:	Astrazeneca
Ingredient:	amitriptyline hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 012703

Adrenergic Uptake Inhibitors
Analgesics, Non-Narcotic
Antidepressive Agents, Tricyclic

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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 012703

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	ELAVIL	amitriptyline hydrochloride	TABLET;ORAL	012703-001	Approved Prior to Jan 1, 1982	3,428,735	⤷ Get Started Free
Astrazeneca	ELAVIL	amitriptyline hydrochloride	TABLET;ORAL	012703-007	Approved Prior to Jan 1, 1982	3,428,735	⤷ Get Started Free
Astrazeneca	ELAVIL	amitriptyline hydrochloride	TABLET;ORAL	012703-005	Approved Prior to Jan 1, 1982	3,428,735	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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