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Last Updated: May 28, 2020

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Details for New Drug Application (NDA): 077584


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NDA 077584 describes PAROXETINE HYDROCHLORIDE, which is a drug marketed by Apotex Inc, Lannett Co Inc, Lupin Ltd, Mylan, Sciecure Pharma Inc, Apotex, Aurobindo Pharma, Jubilant Generics, Mylan Pharms Inc, Oxford Pharms, Roxane, Sun Pharm Inds Inc, Teva, Teva Pharms, Upsher Smith Labs, and Zydus Pharms Usa, and is included in eighteen NDAs. It is available from thirty-six 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. Forty suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.
Summary for 077584
Tradename:PAROXETINE HYDROCHLORIDE
Applicant:Zydus Pharms Usa
Ingredient:paroxetine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077584
Mechanism of ActionSerotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 077584
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 077584 ANDA Unit Dose Services 50436-3933 50436-3933-3 90 TABLET, FILM COATED in 1 BOTTLE (50436-3933-3)
PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 077584 ANDA International Laboratories, LLC 54458-988 54458-988-16 30 TABLET in 1 BOTTLE (54458-988-16)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Mar 7, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Mar 7, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 30MG BASE
Approval Date:Mar 7, 2007TE:ABRLD:No

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