Last Updated: November 8, 2026

Details for New Drug Application (NDA): 203279

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NDA 203279 describes PALIPERIDONE, which is a drug marketed by Actavis Labs Fl Inc, Adaptis, Ajanta Pharma Ltd, Alembic, Amneal Pharms, Apotex, Ascent Pharms Inc, Cspc Ouyi, Dr Reddys, Lupin, Pharmazone, Rk Pharma, Sun Pharm, and Zydus Pharms, and is included in fifteen NDAs. It is available from eighteen suppliers. Additional details are available on the PALIPERIDONE profile page.

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

Summary for 203279

Tradename:	PALIPERIDONE
Applicant:	Apotex
Ingredient:	paliperidone
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	3MG
Approval Date:	Jan 26, 2026	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	6MG
Approval Date:	Jan 26, 2026	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	9MG
Approval Date:	Jan 26, 2026	TE:		RLD:	No

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