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Serving leading biopharmaceutical companies globally:

AstraZeneca
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Teva
Mallinckrodt
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Cerilliant
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Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076219

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NDA 076219 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-seven 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-nine suppliers are listed for this compound. Additional details are available on the mirtazapine profile page.
Summary for 076219
Tradename:MIRTAZAPINE
Applicant:Upsher-smith Labs
Ingredient:mirtazapine
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 076219
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIRTAZAPINE mirtazapine TABLET;ORAL 076219 ANDA Eon Labs, Inc. 0185-0020 0185-0020-01 100 TABLET, FILM COATED in 1 BOTTLE (0185-0020-01)
MIRTAZAPINE mirtazapine TABLET;ORAL 076219 ANDA Eon Labs, Inc. 0185-0020 0185-0020-05 500 TABLET, FILM COATED in 1 BOTTLE (0185-0020-05)

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 leading biopharmaceutical companies globally:

Chubb
McKinsey
Chinese Patent Office
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Moodys
US Army
Covington
Accenture
Novartis

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