BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Julphar
Deloitte
Cantor Fitzgerald
Medtronic
Fuji
Queensland Health
UBS
Moodys
Chubb
Johnson and Johnson

Generated: January 23, 2018

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 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, Pharm Assoc, Silarx, Teva Pharms, Wockhardt, 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 071669
Tradename:DOXEPIN HYDROCHLORIDE
Applicant:Par Pharm
Ingredient:doxepin hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Anxiolytics
Dermatological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 071669
Medical Subject Heading (MeSH) Categories for 071669
Suppliers and Packaging for NDA: 071669
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 071669 ANDA AvKARE, Inc. 42291-247 42291-247-90 90 CAPSULE in 1 BOTTLE (42291-247-90)
DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 071669 ANDA STAT Rx USA LLC 42549-492 42549-492-30 30 CAPSULE in 1 BOTTLE (42549-492-30)

Profile 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:

Express Scripts
Medtronic
Merck
Dow
QuintilesIMS
Argus Health
Farmers Insurance
Healthtrust
Boehringer Ingelheim

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