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Deloitte
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Chinese Patent Office
Cerilliant
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Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076541

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NDA 076541 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-five 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-six suppliers are listed for this compound. Additional details are available on the mirtazapine profile page.
Summary for 076541
Tradename:MIRTAZAPINE
Applicant:Sun Pharm Inds Inc
Ingredient:mirtazapine
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 076541
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIRTAZAPINE mirtazapine TABLET;ORAL 076541 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-8078 N 0615-8078-05
MIRTAZAPINE mirtazapine TABLET;ORAL 076541 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-8078 N 0615-8078-39

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Apr 22, 2004TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Apr 22, 2004TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength45MG
Approval Date:Apr 22, 2004TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
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Colorcon
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Cerilliant
Queensland Health
Merck
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