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Serving leading biopharmaceutical companies globally:

AstraZeneca
Argus Health
US Army
Harvard Business School
Novartis
Fish and Richardson
US Department of Justice
Farmers Insurance
Julphar
Johnson and Johnson

Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076122

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NDA 076122 describes MIRTAZAPINE, which is a drug marketed by Actavis Elizabeth, Actavis Labs Fl Inc, Aurobindo Pharma Ltd, Impax Labs Inc, Zydus Pharms Usa Inc, Apotex Inc, Aurobindo, Ivax Sub Teva Pharms, Mylan, Mylan Pharms Inc, Roxane, Sun Pharm Inds Inc, Teva, Upsher-smith Labs, and Watson Labs, and is included in twenty NDAs. It is available from forty-six suppliers. Additional details are available on the MIRTAZAPINE profile page.

The generic ingredient in MIRTAZAPINE is mirtazapine. There are eighteen drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the mirtazapine profile page.
Summary for 076122
Tradename:MIRTAZAPINE
Applicant:Mylan
Ingredient:mirtazapine
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 076122
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIRTAZAPINE mirtazapine TABLET;ORAL 076122 ANDA Mylan Pharmaceuticals Inc. 0378-3515 N 0378-3515-93
MIRTAZAPINE mirtazapine TABLET;ORAL 076122 ANDA Mylan Pharmaceuticals Inc. 0378-3515 N 0378-3515-70

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Jun 19, 2003TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Jun 19, 2003TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength45MG
Approval Date:Jun 19, 2003TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Federal Trade Commission
McKinsey
Johnson and Johnson
Chinese Patent Office
QuintilesIMS
Queensland Health
Express Scripts
Deloitte

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