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Cerilliant
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Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 071437

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NDA 071437 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 071437
Tradename:DOXEPIN HYDROCHLORIDE
Applicant:Par Pharm
Ingredient:doxepin hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Anxiolytics
Dermatological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 071437
Medical Subject Heading (MeSH) Categories for 071437
Suppliers and Packaging for NDA: 071437
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 071437 ANDA Par Pharmaceutical, Inc. 49884-218 N 49884-218-01
DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 071437 ANDA Physicians Total Care, Inc. 54868-0062 E 54868-0062-0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 25MG BASE
Approval Date:Nov 9, 1987TE:RLD:No

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