BioPharmaceutical Business Intelligence

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Daiichi Sankyo
Farmers Insurance
Federal Trade Commission

Generated: March 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 071918

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NDA 071918 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 Bio Ag, 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 071918
Applicant:Wockhardt Bio Ag
Ingredient:doxepin hydrochloride
Therapeutic Class:Antidepressants
Dermatological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 071918
Medical Subject Heading (MeSH) Categories for 071918
Suppliers and Packaging for NDA: 071918
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXEPIN HYDROCHLORIDE doxepin hydrochloride CONCENTRATE;ORAL 071918 ANDA Morton Grove Pharmaceuticals, Inc. 60432-651 N 60432-651-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CONCENTRATE;ORALStrengthEQ 10MG BASE/ML
Approval Date:Jul 20, 1988TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Boehringer Ingelheim
Harvard Business School
Cantor Fitzgerald
US Army

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