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Serving 500+ biopharmaceutical companies globally:

Cerilliant
Daiichi Sankyo
McKesson
QuintilesIMS
Deloitte
Moodys
US Army
Harvard Business School
US Department of Justice
Cipla

Generated: July 22, 2017

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 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-one 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-one 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:1
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:RXDosage:TABLET;ORALStrength50MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Citi
Novartis
US Army
Chubb
Medtronic
UBS
Argus Health
Federal Trade Commission
Teva
Moodys

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.

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