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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Colorcon
Harvard Business School
Moodys
Cantor Fitzgerald
Express Scripts
Johnson and Johnson
Merck
US Army

Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 071608

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NDA 071608 describes DOXEPIN HYDROCHLORIDE, which is a drug marketed by Amneal Pharms Co, Dava Pharms Inc, Mylan Pharms Inc, New River, Par Pharm, Purepac Pharm, Quantum Pharmics, Sandoz, Sun Pharm Industries, Watson Labs, Watson Labs Teva, Lannett Co Inc, Pharm Assoc, Teva Pharms, Wockhardt Bio Ag, and Actavis Elizabeth, and is included in fifty-six NDAs. It is available from twenty-six suppliers. Additional details are available on the DOXEPIN HYDROCHLORIDE profile page.

The generic ingredient in DOXEPIN HYDROCHLORIDE is doxepin hydrochloride. There are seven drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.
Summary for 071608
Tradename:DOXEPIN HYDROCHLORIDE
Applicant:Par Pharm
Ingredient:doxepin hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Anxiolytics
Dermatological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 071608
Medical Subject Heading (MeSH) Categories for 071608
Suppliers and Packaging for NDA: 071608
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 071608 ANDA Par Pharmaceutical, Inc. 49884-220 N 49884-220-01
DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 071608 ANDA Physicians Total Care, Inc. 54868-2552 E 54868-2552-0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 75MG BASE
Approval Date:Nov 9, 1987TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Express Scripts
Merck
Moodys
US Army
Accenture
AstraZeneca
Chinese Patent Office
Deloitte

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