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Serving leading biopharmaceutical companies globally:

Covington
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Federal Trade Commission
Julphar
McKinsey
Cerilliant
Deloitte
Citi
Cipla
Queensland Health

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202645

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NDA 202645 describes PALIPERIDONE, which is a drug marketed by Actavis Labs Fl Inc and Mylan Pharms Inc and is included in two 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-four 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 202645
Tradename:PALIPERIDONE
Applicant:Actavis Labs Fl Inc
Ingredient:paliperidone
Patents:0
Therapeutic Class:Antipsychotics
Formulation / Manufacturing:see details
Pharmacology for NDA: 202645
Suppliers and Packaging for NDA: 202645
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PALIPERIDONE paliperidone TABLET, EXTENDED RELEASE;ORAL 202645 ANDA Actavis Pharma, Inc. 0591-3692 0591-3692-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-3692-30)
PALIPERIDONE paliperidone TABLET, EXTENDED RELEASE;ORAL 202645 ANDA Actavis Pharma, Inc. 0591-3693 0591-3693-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-3693-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength1.5MG
Approval Date:Aug 3, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength3MG
Approval Date:Aug 3, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength6MG
Approval Date:Aug 3, 2015TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

QuintilesIMS
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Daiichi Sankyo
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Harvard Business School

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