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Generated: September 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076901

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NDA 076901 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: 076901

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

Suppliers and Packaging for NDA: 076901

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIRTAZAPINE
mirtazapine
TABLET, ORALLY DISINTEGRATING;ORAL 076901 ANDA Teva Pharmaceuticals USA, Inc. 0093-7303 0093-7303-65 30 BLISTER PACK in 1 BOX (0093-7303-65) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0093-7303-18)
MIRTAZAPINE
mirtazapine
TABLET, ORALLY DISINTEGRATING;ORAL 076901 ANDA Teva Pharmaceuticals USA, Inc. 0093-7304 0093-7304-65 30 BLISTER PACK in 1 BOX (0093-7304-65) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0093-7304-18)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength15MG
Approval Date:Jun 28, 2005TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength30MG
Approval Date:Jun 28, 2005TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength45MG
Approval Date:Jun 28, 2005TE:ABRLD:No


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US Army
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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