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Last Updated: December 15, 2025

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, Aiping Pharm Inc, Am Therap, Ani Pharms, Aurobindo Pharma Usa, Breckenridge, Copley Pharm, Halsey, Lederle, Mankind Pharma, Mutual Pharm, Par Pharm, Ph Health, Pliva, Purepac Pharm, Rising, Roxane, Rubicon Research, Sandoz, Sun Pharm Inds Inc, Superpharm, Teva, Ucb Inc, Unichem, Unique Pharm, Usl Pharma, Vangard, West Ward, and Zydus Pharms, and is included in one hundred and twenty NDAs. It is available from thirty-seven 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. Thirty-seven suppliers are listed for this compound. Additional details are available on the amitriptyline hydrochloride profile page.
Summary for 040218
Tradename:AMITRIPTYLINE HYDROCHLORIDE
Applicant:Ph Health
Ingredient:amitriptyline hydrochloride
Patents:0
Medical Subject Heading (MeSH) Categories for 040218
Adrenergic Uptake Inhibitors
Analgesics, Non-Narcotic
Antidepressive Agents, Tricyclic

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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