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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 205618


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NDA 205618 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, Inventia, Lupin Ltd, Rk Pharma, Sun Pharm, and Zydus Pharms, and is included in fourteen 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 205618
Tradename:PALIPERIDONE
Applicant:Sun Pharm
Ingredient:paliperidone
Patents:0
Pharmacology for NDA: 205618
Suppliers and Packaging for NDA: 205618
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PALIPERIDONE paliperidone TABLET, EXTENDED RELEASE;ORAL 205618 ANDA Major Pharmaceuticals 0904-6935 0904-6935-61 100 BLISTER PACK in 1 CARTON (0904-6935-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
PALIPERIDONE paliperidone TABLET, EXTENDED RELEASE;ORAL 205618 ANDA Major Pharmaceuticals 0904-6936 0904-6936-61 100 BLISTER PACK in 1 CARTON (0904-6936-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength1.5MG
Approval Date:Apr 6, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength3MG
Approval Date:Apr 6, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength6MG
Approval Date:Apr 6, 2018TE:ABRLD:No

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Preferred Citation:

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