Details for New Drug Application (NDA): 040816

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NDA 040816 describes AMITRIPTYLINE HYDROCHLORIDE, which is a drug marketed by Watson Labs, Accord Hlthcare, Aiping Pharm Inc, Am Therap, Ani Pharms, Aurobindo Pharma Usa, Breckenridge, Copley Pharm, Endo Operations, Halsey, Lederle, Mankind Pharma, Mutual Pharm, Par Pharm, Pliva, Purepac Pharm, Rising, Roxane, Rubicon, Sandoz, Sun Pharm Inds Inc, Superpharm, Teva, Ucb Inc, Unichem, Usl Pharma, Vangard, West Ward, and Zydus Pharms, and is included in one hundred and nineteen NDAs. It is available from thirty-eight suppliers. Additional details are available on the AMITRIPTYLINE HYDROCHLORIDE profile page.

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

Tradename:	AMITRIPTYLINE HYDROCHLORIDE
Applicant:	Sun Pharm Inds Inc
Ingredient:	amitriptyline hydrochloride
Patents:	0

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

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Jun 27, 2008	TE:		RLD:	No

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Jun 27, 2008	TE:		RLD:	No

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Jun 27, 2008	TE:		RLD:	No

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