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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 091427

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NDA 091427 describes PAROXETINE HYDROCHLORIDE, which is a drug marketed by 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-five 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 091427

Tradename:	PAROXETINE HYDROCHLORIDE
Applicant:	Aurobindo Pharma Usa
Ingredient:	paroxetine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 37.5MG BASE
Approval Date:	Apr 14, 2011	TE:	AB	RLD:	No

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