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Generated: April 20, 2018

DrugPatentWatch Database Preview

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, Mylan Pharms Inc, and Sun Pharma Global, and is included in three NDAs. It is available from four suppliers. Additional details are available on the PALIPERIDONE profile page.

The generic ingredient in PALIPERIDONE is paliperidone. There are thirty-six drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the paliperidone profile page.
Summary for 203802
Tradename:PALIPERIDONE
Applicant:Mylan Pharms Inc
Ingredient:paliperidone
Patents:0
Therapeutic Class:Antipsychotics
Formulation / Manufacturing:see details
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 Mylan Pharmaceuticals Inc. 0378-3978 N 0378-3978-93
PALIPERIDONE paliperidone TABLET, EXTENDED RELEASE;ORAL 203802 ANDA Mylan Pharmaceuticals Inc. 0378-3979 N 0378-3979-93

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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