Make Better Decisions

  • Analyze global market entry opportunities
  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information
➤ Start Trial

or, See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Federal Trade Commission
McKesson
Deloitte
QuintilesIMS
Boehringer Ingelheim
UBS
AstraZeneca
Cerilliant
Chubb
Cipla

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203802

« Back to Dashboard

NDA 203802 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-five 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 0378-3978-93 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-3978-93)
PALIPERIDONE paliperidone TABLET, EXTENDED RELEASE;ORAL 203802 ANDA Mylan Pharmaceuticals Inc. 0378-3979 0378-3979-93 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

McKesson
Fish and Richardson
Daiichi Sankyo
Harvard Business School
Chinese Patent Office
Healthtrust
Mallinckrodt
Farmers Insurance
Novartis

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

botpot