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Last Updated: November 25, 2024

Details for New Drug Application (NDA): 215003


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NDA 215003 describes PAROXETINE HYDROCHLORIDE, which is a drug marketed by Apotex Inc, Novitium Pharma, Aurobindo Pharma Usa, Cadila Pharms Ltd, Cspc Ouyi, Epic Pharma Llc, Lannett Co Inc, Lupin Ltd, Prinston Inc, Sciecure Pharma Inc, Apotex, Aurobindo Pharma, Chartwell Rx, Jubilant Generics, Mylan, Norvium Bioscience, Oxford Pharms, Roxane, Sun Pharm Inds Inc, Teva Pharms, Upsher Smith Labs, Yiling, and Zydus Pharms Usa, and is included in twenty-four NDAs. It is available from forty-one 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-four suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.
Summary for 215003
Tradename:PAROXETINE HYDROCHLORIDE
Applicant:Novitium Pharma
Ingredient:paroxetine hydrochloride
Patents:0
Pharmacology for NDA: 215003
Mechanism of ActionSerotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 215003
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PAROXETINE HYDROCHLORIDE paroxetine hydrochloride SUSPENSION;ORAL 215003 ANDA ANI Pharmaceuticals, Inc. 70954-319 70954-319-10 250 mL in 1 BOTTLE (70954-319-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrengthEQ 10MG BASE/5ML
Approval Date:Sep 3, 2021TE:ABRLD:No

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