Last Updated: August 8, 2026

Details for New Drug Application (NDA): 220104

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NDA 220104 describes MIRTAZAPINE, which is a drug marketed by Actavis Elizabeth, Actavis Labs Fl Inc, Aurobindo Pharma, Impax Labs Inc, Square Pharms Plc, Allied, Annora Pharma, Apotex, Aurobindo, Chartwell Rx, Ivax Sub Teva Pharms, Micro Labs, Mylan, Novitium Pharma, Prasco, Roxane, Sun Pharm Inds Inc, Teva, Upsher Smith Labs, and Watson Labs, and is included in twenty-four NDAs. It is available from thirty-five 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-six suppliers are listed for this compound. Additional details are available on the mirtazapine profile page.

Summary for 220104

Tradename:	MIRTAZAPINE
Applicant:	Micro Labs
Ingredient:	mirtazapine
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	7.5MG
Approval Date:	May 19, 2026	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	15MG
Approval Date:	May 19, 2026	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	30MG
Approval Date:	May 19, 2026	TE:	AB	RLD:	No

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