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Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076921

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NDA 076921 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 thirty-eight 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. Thirty-nine suppliers are listed for this compound. Additional details are available on the mirtazapine profile page.
Summary for 076921
Tradename:MIRTAZAPINE
Applicant:Aurobindo
Ingredient:mirtazapine
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 076921
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIRTAZAPINE mirtazapine TABLET;ORAL 076921 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7870 N 0615-7870-39
MIRTAZAPINE mirtazapine TABLET;ORAL 076921 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7870 N 0615-7870-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7.5MG
Approval Date:Oct 22, 2004TE:ABRLD:No

Profile for product number 002

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

Profile for product number 003

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

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