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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 076541


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NDA 076541 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 076541
Tradename:MIRTAZAPINE
Applicant:Sun Pharm Inds Inc
Ingredient:mirtazapine
Patents:0
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 AvKARE 42291-494 42291-494-30 30 TABLET in 1 BOTTLE (42291-494-30)
MIRTAZAPINE mirtazapine TABLET;ORAL 076541 ANDA AvKARE 42291-494 42291-494-90 90 TABLET in 1 BOTTLE (42291-494-90)

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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Preferred Citation:

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