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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 218755


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NDA 218755 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 218755
Tradename:PALIPERIDONE
Applicant:Everest Lifesciences
Ingredient:paliperidone
Patents:0
Pharmacology for NDA: 218755
Suppliers and Packaging for NDA: 218755
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PALIPERIDONE paliperidone TABLET, EXTENDED RELEASE;ORAL 218755 ANDA Westminster Pharmaceuticals, LLC 69367-432 69367-432-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69367-432-30)
PALIPERIDONE paliperidone TABLET, EXTENDED RELEASE;ORAL 218755 ANDA Westminster Pharmaceuticals, LLC 69367-433 69367-433-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69367-433-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength1.5MG
Approval Date:Sep 4, 2025TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength3MG
Approval Date:Sep 4, 2025TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength6MG
Approval Date:Sep 4, 2025TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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