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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 076921


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NDA 076921 describes MIRTAZAPINE, which is a drug marketed by Acme Labs, Actavis Elizabeth, Actavis Labs Fl Inc, Aurobindo Pharma, Impax Labs Inc, Annora Pharma, Apotex, Aurobindo, Chartwell Rx, Ivax Sub Teva Pharms, Mylan, Pharmobedient, Prasco, Roxane, Sun Pharm Inds Inc, Teva, Upsher Smith Labs, and Watson Labs, and is included in twenty-two NDAs. It is available from thirty 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-one 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
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 0615-8268 0615-8268-05 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8268-05)
MIRTAZAPINE mirtazapine TABLET;ORAL 076921 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-8268 0615-8268-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8268-39)

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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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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