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Generated: September 22, 2017

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Details for New Drug Application (NDA): 086009

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

Summary for NDA: 086009

Tradename:	1
Applicant:	1
Ingredient:	1
Patents:	0
Therapeutic Class:	Antidepressants
Formulation / Manufacturing:	see details

Pharmacology for NDA: 086009

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	0378-2610-01	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2610-01)
AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride	TABLET;ORAL	086009	ANDA	Mylan Pharmaceuticals Inc.	0378-2610	0378-2610-10	1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2610-10)

Summary 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

Summary 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

Summary 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.