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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Queensland Health
Chubb
AstraZeneca
UBS
Teva
Chinese Patent Office
Daiichi Sankyo
Cipla

Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040218

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NDA 040218 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 forty-five 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-five suppliers are listed for this compound. Additional details are available on the amitriptyline hydrochloride profile page.
Summary for 040218
Tradename:AMITRIPTYLINE HYDROCHLORIDE
Applicant:Vintage Pharms
Ingredient:amitriptyline hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Pharmacology for NDA: 040218
Medical Subject Heading (MeSH) Categories for 040218
Suppliers and Packaging for NDA: 040218
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 040218 ANDA C.O. Truxton, Inc. 0463-6351 N 0463-6351-10
AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 040218 ANDA C.O. Truxton, Inc. 0463-6352 N 0463-6352-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Sep 11, 1997TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Sep 11, 1997TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Sep 11, 1997TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
McKesson
Colorcon
Medtronic
Julphar
Daiichi Sankyo
Healthtrust
Fish and Richardson
Moodys

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