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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 076689

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NDA 076689 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 076689

Tradename:	MIRTAZAPINE
Applicant:	Actavis Elizabeth
Ingredient:	mirtazapine
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	15MG
Approval Date:	Aug 31, 2005	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	30MG
Approval Date:	Aug 31, 2005	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	45MG
Approval Date:	Aug 31, 2005	TE:		RLD:	No

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