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Details for New Drug Application (NDA): 071685

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NDA 071685 describes DOXEPIN HYDROCHLORIDE, which is a drug marketed by Sun Pharm Inds, Par Pharm, Purepac Pharm, Teva Pharms, Wockhardt, Silarx, Pharm Assoc, Sandoz, Watson Labs, Quantum Pharmics, Mylan Pharms Inc, Actavis Elizabeth, Dava Pharms Inc, and New River, and is included in fifty-five NDAs. It is available from twenty-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. Twenty-eight suppliers are listed for this compound. There are four tentative approvals for this compound. Additional details are available on the doxepin hydrochloride profile page.

Summary for NDA: 071685

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 10MG BASE
Approval Date:Jan 5, 1988TE:RLD:No

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