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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts

Generated: March 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 085969

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NDA 085969 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 085969
Ingredient:amitriptyline hydrochloride
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Pharmacology for NDA: 085969
Medical Subject Heading (MeSH) Categories for 085969
Suppliers and Packaging for NDA: 085969
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 085969 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-0828 N 0615-0828-39
AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 085969 ANDA Sandoz Inc 0781-1486 N 0781-1486-31

Profile for product number 001

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

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
US Army
Argus Health
Farmers Insurance

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