BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents
➤ 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:

Harvard Business School
Johnson and Johnson
Argus Health

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 009768

« Back to Dashboard

NDA 009768 describes PLAQUENIL, which is a drug marketed by Concordia Pharms Inc and is included in one NDA. It is available from six suppliers. Additional details are available on the PLAQUENIL profile page.

The generic ingredient in PLAQUENIL is hydroxychloroquine sulfate. There are fifteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the hydroxychloroquine sulfate profile page.
Summary for 009768
Applicant:Concordia Pharms Inc
Ingredient:hydroxychloroquine sulfate
Therapeutic Class:Antiparasitics
Formulation / Manufacturing:see details
Pharmacology for NDA: 009768
Medical Subject Heading (MeSH) Categories for 009768
Suppliers and Packaging for NDA: 009768
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PLAQUENIL hydroxychloroquine sulfate TABLET;ORAL 009768 NDA AvKARE, Inc. 42291-335 42291-335-90 90 TABLET in 1 BOTTLE (42291-335-90)
PLAQUENIL hydroxychloroquine sulfate TABLET;ORAL 009768 NDA AUTHORIZED GENERIC Aphena Pharma Solutions - Tennessee, LLC 43353-051 43353-051-53 60 TABLET in 1 BOTTLE (43353-051-53)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Boehringer Ingelheim
Federal Trade Commission
US Department of Justice

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.