Last Updated: September 28, 2026

Details for New Drug Application (NDA): 204452


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NDA 204452 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 204452
Tradename:PALIPERIDONE
Applicant:Inventia
Ingredient:paliperidone
Patents:0
Pharmacology for NDA: 204452
Suppliers and Packaging for NDA: 204452
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PALIPERIDONE paliperidone TABLET, EXTENDED RELEASE;ORAL 204452 ANDA ANI Pharmaceuticals, Inc. 43975-349 43975-349-03 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43975-349-03)
PALIPERIDONE paliperidone TABLET, EXTENDED RELEASE;ORAL 204452 ANDA ANI Pharmaceuticals, Inc. 43975-350 43975-350-03 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43975-350-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength1.5MG
Approval Date:Jun 12, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength3MG
Approval Date:Jun 12, 2019TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength6MG
Approval Date:Jun 12, 2019TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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