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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 205559

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NDA 205559 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 nineteen 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. Twenty suppliers are listed for this compound. Additional details are available on the paliperidone profile page.

Summary for 205559

Tradename:	PALIPERIDONE
Applicant:	Dr Reddys
Ingredient:	paliperidone
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	3MG
Approval Date:	Feb 19, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	6MG
Approval Date:	Feb 19, 2025	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	9MG
Approval Date:	Feb 19, 2025	TE:	AB	RLD:	No

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