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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 202645

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NDA 202645 describes PALIPERIDONE, which is a drug marketed by Actavis Labs Fl Inc, Ajanta Pharma Ltd, Alembic, Amneal Pharms, Ascent Pharms Inc, Cspc Ouyi, Dr Reddys, Everest Lifesciences, Inventia, Lupin Ltd, Rk Pharma, Sun Pharm, and Zydus Pharms, and is included in thirteen NDAs. It is available from eighteen suppliers. Additional details are available on the PALIPERIDONE profile page.

The generic ingredient in PALIPERIDONE is paliperidone. There are thirty-eight drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the paliperidone profile page.

Summary for 202645

Tradename:	PALIPERIDONE
Applicant:	Actavis Labs Fl Inc
Ingredient:	paliperidone
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	1.5MG
Approval Date:	Aug 3, 2015	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	3MG
Approval Date:	Aug 3, 2015	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	6MG
Approval Date:	Aug 3, 2015	TE:		RLD:	No

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