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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Express Scripts
Farmers Insurance
Harvard Business School
Daiichi Sankyo
Boehringer Ingelheim

Generated: October 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 071669

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NDA 071669 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, Amneal Pharms Co, New River, and Watson Labs Teva, 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 NDA: 071669

Therapeutic Class:Antidepressants
Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 071669

Suppliers and Packaging for NDA: 071669

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
doxepin hydrochloride
CAPSULE;ORAL 071669 ANDA AvKARE, Inc. 42291-247 42291-247-90 90 CAPSULE in 1 BOTTLE (42291-247-90)
doxepin hydrochloride
CAPSULE;ORAL 071669 ANDA STAT Rx USA LLC 42549-492 42549-492-30 30 CAPSULE in 1 BOTTLE (42549-492-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 150MG BASE
Approval Date:Nov 9, 1987TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Argus Health
Fish and Richardson
Express Scripts
US Army
US Department of Justice
Queensland Health

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