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Last Updated: December 28, 2025

Details for New Drug Application (NDA): 076219

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NDA 076219 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 076219

Tradename:	MIRTAZAPINE
Applicant:	Chartwell Rx
Ingredient:	mirtazapine
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	15MG
Approval Date:	Jun 19, 2003	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	30MG
Approval Date:	Jun 19, 2003	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	45MG
Approval Date:	Jun 19, 2003	TE:	AB	RLD:	No

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