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

Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Cantor Fitzgerald
UBS
Federal Trade Commission
Julphar
Daiichi Sankyo
QuintilesIMS
Argus Health
Express Scripts

Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017473

« Back to Dashboard

NDA 017473 describes ORAP, which is a drug marketed by Teva and Concordia Pharms Inc and is included in three NDAs. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the ORAP profile page.

The generic ingredient in ORAP is prednisolone sodium phosphate. There are eighty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate profile page.
Summary for 017473
Tradename:ORAP
Applicant:Teva
Ingredient:pimozide
Patents:0
Therapeutic Class:Antipsychotics
Formulation / Manufacturing:see details
Pharmacology for NDA: 017473
Medical Subject Heading (MeSH) Categories for 017473
Suppliers and Packaging for NDA: 017473
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ORAP pimozide TABLET;ORAL 017473 NDA Teva Select Brands 57844-151 N 57844-151-01
ORAP pimozide TABLET;ORAL 017473 NDA Teva Select Brands 57844-198 N 57844-198-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Jul 31, 1984TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Aug 27, 1997TE:ABRLD:Yes

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Moodys
QuintilesIMS
Colorcon
Dow
Cipla
Boehringer Ingelheim
Cantor Fitzgerald
Queensland Health

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.