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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076122

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NDA 076122 describes MIRTAZAPINE, which is a drug marketed by Actavis Elizabeth, Actavis Labs Fl Inc, Aurobindo Pharma Ltd, Impax Labs Inc, Zydus Pharms Usa Inc, 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 forty-seven 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-nine suppliers are listed for this compound. Additional details are available on the mirtazapine profile page.

Summary for 076122

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 076122

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIRTAZAPINE mirtazapine TABLET;ORAL 076122 ANDA Mylan Pharmaceuticals Inc. 0378-3515 0378-3515-10 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3515-10)
MIRTAZAPINE mirtazapine TABLET;ORAL 076122 ANDA Mylan Pharmaceuticals Inc. 0378-3515 0378-3515-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3515-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Jun 19, 2003TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Jun 19, 2003TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength45MG
Approval Date:Jun 19, 2003TE:ABRLD:No


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