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Last Updated: September 26, 2020

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Details for New Drug Application (NDA): 071502

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NDA 071502 describes DOXEPIN HYDROCHLORIDE, which is a drug marketed by Ajanta Pharma Ltd, Amneal Pharms Co, Aurobindo Pharma Ltd, Contract Pharmacal, Dava Pharms Inc, Lannett Co Inc, Mylan Pharms Inc, New River, Par Pharm, Purepac Pharm, Quantum Pharmics, Sandoz, Sun Pharm Industries, Taro Pharm Inds Ltd, Watson Labs, Watson Labs Teva, Pharm Assoc, Teva Pharms, Wockhardt Bio Ag, Actavis Elizabeth, Mylan, and Par Pharm Inc, and is included in fifty-seven NDAs. It is available from twenty-three 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. Twenty-five suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.
Summary for 071502
Tradename:DOXEPIN HYDROCHLORIDE
Applicant:Sun Pharm Industries
Ingredient:doxepin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 071502

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 25MG BASE
Approval Date:Feb 18, 1988TE:RLD:No

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