Details for New Drug Application (NDA): 076312

NDA 076312 describes MIRTAZAPINE, which is a drug marketed by Actavis Elizabeth, Actavis Labs Fl Inc, Aurobindo Pharma, Impax Labs Inc, Square Pharms, Apotex Inc, Aurobindo, Chartwell Rx, Ivax Sub Teva Pharms, Mylan, Norvium Bioscience, Prasco, Roxane, Sun Pharm Inds Inc, Teva, Upsher Smith Labs, and Watson Labs, and is included in twenty-one NDAs. It is available from thirty-four 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-five suppliers are listed for this compound. Additional details are available on the mirtazapine profile page.

Summary for 076312

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

Suppliers and Packaging for NDA: 076312

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MIRTAZAPINE	mirtazapine	TABLET;ORAL	076312	ANDA	Aphena Pharma Solutions - Tennessee, LLC	71610-121	71610-121-09	9000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-121-09)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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