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Generated: May 25, 2017

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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 Impax Labs Inc, Actavis Labs Fl Inc, Actavis Elizabeth, Watson Labs, Teva, Upsher-smith Labs, Aurobindo, Mylan, Sun Pharm Inds Inc, Ivax Sub Teva Pharms, Apotex Inc, Roxane, Aurobindo Pharma Ltd, and Mylan Pharms Inc, and is included in nineteen NDAs. It is available from forty-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. Forty-seven suppliers are listed for this compound. Additional details are available on the mirtazapine profile page.

Summary for NDA: 077666

Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 077666

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
TABLET;ORAL 077666 ANDA A-S Medication Solutions 50090-1019 50090-1019-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-1019-0)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

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