Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012703
Company: ASTRAZENECA

• Other Important Information from FDA

Products on NDA 12703

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ELAVIL	AMITRIPTYLINE HYDROCHLORIDE	10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
ELAVIL	AMITRIPTYLINE HYDROCHLORIDE	25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
ELAVIL	AMITRIPTYLINE HYDROCHLORIDE	50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
ELAVIL	AMITRIPTYLINE HYDROCHLORIDE	75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
ELAVIL	AMITRIPTYLINE HYDROCHLORIDE	100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
ELAVIL	AMITRIPTYLINE HYDROCHLORIDE	150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No