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Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076901

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NDA 076901 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 076901
Tradename:MIRTAZAPINE
Applicant:Impax Labs Inc
Ingredient:mirtazapine
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 076901
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIRTAZAPINE mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 076901 ANDA Teva Pharmaceuticals USA, Inc. 0093-7303 N 0093-7303-65
MIRTAZAPINE mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 076901 ANDA Teva Pharmaceuticals USA, Inc. 0093-7304 N 0093-7304-65

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength15MG
Approval Date:Jun 28, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength30MG
Approval Date:Jun 28, 2005TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength45MG
Approval Date:Jun 28, 2005TE:ABRLD:No

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