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Last Updated: August 4, 2021

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Details for New Drug Application (NDA): 077666

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NDA 077666 describes MIRTAZAPINE, which is a drug marketed by Actavis Elizabeth, Actavis Labs Fl Inc, Aurobindo Pharma Ltd, Impax Labs Inc, Zydus Pharms, Apotex Inc, Aurobindo, Ivax Sub Teva Pharms, Mylan, Mylan Pharms Inc, Roxane, Sun Pharm Inds Inc, Teva, Upsher Smith Labs, and Watson Labs, and is included in twenty 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 077666
Applicant:Apotex Inc
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 077666
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIRTAZAPINE mirtazapine TABLET;ORAL 077666 ANDA Major Pharmaceuticals 0904-6519 0904-6519-61 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-6519-61) > 1 TABLET, FILM COATED in 1 BLISTER PACK
MIRTAZAPINE mirtazapine TABLET;ORAL 077666 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-378 43353-378-15 15 TABLET, FILM COATED in 1 BOTTLE (43353-378-15)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Aug 22, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Aug 22, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength45MG
Approval Date:Aug 22, 2007TE:ABRLD:No

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