Last Updated: May 11, 2026

Details for New Drug Application (NDA): 209748

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NDA 209748 describes PAROXETINE HYDROCHLORIDE, which is a drug marketed by Annora Pharma, Apotex Inc, Novitium Pharma, Alembic, 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, Oxford Pharms, Pharmobedient, Roxane, Sun Pharm Inds Inc, Teva Pharms, Upsher Smith Labs, Yiling, and Zydus Pharms Usa, and is included in twenty-six 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 209748

Tradename:	PAROXETINE HYDROCHLORIDE
Applicant:	Prinston Inc
Ingredient:	paroxetine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 12.5MG BASE
Approval Date:	Jan 4, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 25MG BASE
Approval Date:	Jan 4, 2024	TE:	AB	RLD:	No

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