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Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 086009

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NDA 086009 describes AMITRIPTYLINE HYDROCHLORIDE, which is a drug marketed by Watson Labs, Accord Hlthcare, Am Therap, Ani Pharms Inc, Copley Pharm, Halsey, Lederle, Mutual Pharm, Mylan, Par Pharm, Pliva, Purepac Pharm, Roxane, Sandoz, Sun Pharm Inds Inc, Superpharm, Teva, Ucb Inc, Usl Pharma, Vangard, Vintage Pharms, West Ward, and Zydus Pharms Usa Inc, and is included in one hundred and eighteen NDAs. It is available from thirty-seven 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-seven suppliers are listed for this compound. Additional details are available on the amitriptyline hydrochloride profile page.

Summary for 086009

Tradename:	AMITRIPTYLINE HYDROCHLORIDE
Applicant:	Mylan
Ingredient:	amitriptyline hydrochloride
Patents:	0
Therapeutic Class:	Antidepressants
Formulation / Manufacturing:	see details

Pharmacology for NDA: 086009

Medical Subject Heading (MeSH) Categories for 086009

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

Suppliers and Packaging for NDA: 086009

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride	TABLET;ORAL	086009	ANDA	Mylan Pharmaceuticals Inc.	0378-2610	N	0378-2610-10
AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride	TABLET;ORAL	086009	ANDA	Mylan Pharmaceuticals Inc.	0378-2610	N	0378-2610-01

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	No

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