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Serving 500+ biopharmaceutical companies globally:

Covington
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Colorcon
McKesson
Chinese Patent Office
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Generated: August 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078902

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NDA 078902 describes PAROXETINE HYDROCHLORIDE, which is a drug marketed by Mylan, Aurobindo Pharma, Mylan Pharms Inc, Teva, Roxane, Jubilant Generics, Lupin Ltd, Kremers Urban Pharms, Apotex, Upsher-smith Labs, Oxford Pharms, Teva Pharms, Zydus Pharms Usa, Sun Pharm Inds Inc, and Apotex Inc, and is included in seventeen NDAs. It is available from fifty-two suppliers. Additional details are available on the PAROXETINE HYDROCHLORIDE profile page.

The generic ingredient in PAROXETINE HYDROCHLORIDE is paroxetine hydrochloride. There are thirty drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.

Summary for NDA: 078902

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

Pharmacology for NDA: 078902

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 078902

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PAROXETINE HYDROCHLORIDE
paroxetine hydrochloride
TABLET;ORAL 078902 ANDA Mylan Pharmaceuticals Inc. 0378-7001 0378-7001-10 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7001-10)
PAROXETINE HYDROCHLORIDE
paroxetine hydrochloride
TABLET;ORAL 078902 ANDA Mylan Pharmaceuticals Inc. 0378-7001 0378-7001-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7001-93)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Mar 13, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Mar 13, 2008TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 30MG BASE
Approval Date:Mar 13, 2008TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
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Cipla
Dow
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