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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Healthtrust
QuintilesIMS
Federal Trade Commission
Moodys
Baxter
Cerilliant
Daiichi Sankyo
Harvard Business School

Generated: August 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077376

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NDA 077376 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-seven suppliers are listed for this compound. Additional details are available on the mirtazapine profile page.
Summary for 077376
Tradename:MIRTAZAPINE
Applicant:Aurobindo Pharma Ltd
Ingredient:mirtazapine
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 077376
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIRTAZAPINE mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 077376 ANDA Cardinal Health 55154-8335 N 55154-8335-6
MIRTAZAPINE mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 077376 ANDA Rising Health, LLC 57237-011 N 57237-011-06

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength15MG
Approval Date:Dec 8, 2005TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength30MG
Approval Date:Dec 8, 2005TE:ABRLD:No

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength45MG
Approval Date:Feb 28, 2006TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
UBS
Dow
Medtronic
Fish and Richardson
Accenture
Deloitte
AstraZeneca
US Army

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