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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 203802


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NDA 203802 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 203802
Tradename:PALIPERIDONE
Applicant:Rk Pharma
Ingredient:paliperidone
Patents:0
Pharmacology for NDA: 203802
Suppliers and Packaging for NDA: 203802
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PALIPERIDONE paliperidone TABLET, EXTENDED RELEASE;ORAL 203802 ANDA Archis Pharma LLC 72819-157 72819-157-03 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72819-157-03)
PALIPERIDONE paliperidone TABLET, EXTENDED RELEASE;ORAL 203802 ANDA Archis Pharma LLC 72819-158 72819-158-03 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72819-158-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength1.5MG
Approval Date:Sep 24, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength3MG
Approval Date:Sep 24, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength6MG
Approval Date:Sep 24, 2015TE:ABRLD:No

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Preferred Citation:

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