Last Updated: September 24, 2026

Details for New Drug Application (NDA): 217445

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NDA 217445 describes PALIPERIDONE, which is a drug marketed by Actavis Labs Fl Inc, Ajanta Pharma Ltd, Alembic, Amneal Pharms, Apotex, Ascent Pharms Inc, Cspc Ouyi, Dr Reddys, Eskayef, I3 Pharms, Inventia, Lupin, 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 217445

Tradename:	PALIPERIDONE
Applicant:	Zydus Pharms
Ingredient:	paliperidone
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	1.5MG
Approval Date:	Oct 8, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	3MG
Approval Date:	Oct 8, 2024	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	6MG
Approval Date:	Oct 8, 2024	TE:	AB	RLD:	No

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