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Generated: November 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203854

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NDA 203854 describes PAROXETINE, which is a drug marketed by Prinston Inc, 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, Zydus Pharms Usa, and Actavis Labs Fl Inc, and is included in twenty-one NDAs. It is available from eleven suppliers. Additional details are available on the PAROXETINE profile page.

The generic ingredient in PAROXETINE is paroxetine mesylate. There are thirty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the paroxetine mesylate profile page.
Summary for 203854
Tradename:PAROXETINE
Applicant:Prinston Inc
Ingredient:paroxetine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203854
Mechanism of ActionSerotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 203854
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PAROXETINE paroxetine hydrochloride TABLET;ORAL 203854 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7985 0615-7985-05 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-7985-05)
PAROXETINE paroxetine hydrochloride TABLET;ORAL 203854 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7985 0615-7985-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7985-39)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Oct 31, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Oct 31, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 30MG BASE
Approval Date:Oct 31, 2014TE:ABRLD:No

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