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Last Updated: October 7, 2022

Details for New Drug Application (NDA): 072376


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NDA 072376 describes DOXEPIN HYDROCHLORIDE, which is a drug marketed by Ajanta Pharma Ltd, Alembic Pharms Ltd, Amneal Pharms Co, Appco, Aurobindo Pharma Ltd, Chartwell Rx, Contract Pharmacal, Dava Pharms Inc, Edenbridge Pharms, Epic Pharma Llc, Jubilant Cadista, Lannett Co Inc, Leading Pharma Llc, Mankind Pharma, MSN, 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, Rk Pharma, and Strides Pharma, and is included in sixty-seven NDAs. It is available from thirty-four 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-six suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.
Summary for 072376
Tradename:DOXEPIN HYDROCHLORIDE
Applicant:Quantum Pharmics
Ingredient:doxepin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 072376

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 150MG BASE
Approval Date:Mar 15, 1989TE:RLD:No

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