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Generated: August 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076119

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NDA 076119 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, Mylan Pharms Inc, and Zydus Pharms Usa Inc, and is included in twenty NDAs. It is available from forty-eight 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. Fifty suppliers are listed for this compound. Additional details are available on the mirtazapine profile page.

Summary for NDA: 076119

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

Suppliers and Packaging for NDA: 076119

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIRTAZAPINE
mirtazapine
TABLET;ORAL 076119 ANDA Teva Pharmaceuticals USA Inc 0093-7206 0093-7206-56 30 TABLET, FILM COATED in 1 BOTTLE (0093-7206-56)
MIRTAZAPINE
mirtazapine
TABLET;ORAL 076119 ANDA Teva Pharmaceuticals USA Inc 0093-7207 0093-7207-56 30 TABLET, FILM COATED in 1 BOTTLE (0093-7207-56)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Jan 24, 2003TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Jan 24, 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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Serving 500+ biopharmaceutical companies globally:

Citi
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Federal Trade Commission

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