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Generated: December 11, 2018

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Details for New Drug Application (NDA): 204744

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NDA 204744 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 forty-nine 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-three suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.
Summary for 204744
Tradename:PAROXETINE HYDROCHLORIDE
Applicant:Lannett Co Inc
Ingredient:paroxetine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204744
Mechanism of ActionSerotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 204744
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 204744 ANDA Kremers Urban Pharmaceuticals Inc. 62175-470 62175-470-32 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62175-470-32)
PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 204744 ANDA Kremers Urban Pharmaceuticals Inc. 62175-470 62175-470-41 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62175-470-41)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 12.5MG BASE
Approval Date:Jun 10, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 25MG BASE
Approval Date:Jun 10, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 37.5MG BASE
Approval Date:Jun 10, 2016TE:ABRLD:No

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