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Generated: November 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 088425

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NDA 088425 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, Pliva, and Zydus Pharms Usa Inc, and is included in one hundred and eighteen 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 088425

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

Medical Subject Heading (MeSH) Categories for 088425

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Apr 30, 1984TE:RLD:No


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Serving leading biopharmaceutical companies globally:

Argus Health
Merck
Mallinckrodt
QuintilesIMS
Queensland Health
Federal Trade Commission
McKesson
Johnson and Johnson
Novartis
Accenture

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