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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 205798


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NDA 205798 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 205798
Tradename:MIRTAZAPINE
Applicant:Acme Labs
Ingredient:mirtazapine
Patents:0
Suppliers and Packaging for NDA: 205798
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIRTAZAPINE mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 205798 ANDA Bryant Ranch Prepack 71335-2471 71335-2471-1 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-2471-1)
MIRTAZAPINE mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 205798 ANDA Viona Pharmaceuticals Inc. 72578-103 72578-103-84 5 BLISTER PACK in 1 CARTON (72578-103-84) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (72578-103-69)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength15MG
Approval Date:Jun 1, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength30MG
Approval Date:Jun 1, 2017TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength45MG
Approval Date:Jun 1, 2017TE:ABRLD:No

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Preferred Citation:

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