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:

Deloitte
Johnson and Johnson
Julphar
Fish and Richardson
QuintilesIMS
Dow
Daiichi Sankyo
Cipla
Mallinckrodt
Cantor Fitzgerald

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 016885

« Back to Dashboard

NDA 016885 describes LYSODREN, which is a drug marketed by Bristol Myers Squibb and is included in one NDA. It is available from one supplier. Additional details are available on the LYSODREN profile page.

The generic ingredient in LYSODREN is mitotane. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the mitotane profile page.
Summary for 016885
Tradename:LYSODREN
Applicant:Bristol Myers Squibb
Ingredient:mitotane
Patents:0
Therapeutic Class:Hormonal Agents, Suppressant (Adrenal)
Formulation / Manufacturing:see details
Pharmacology for NDA: 016885
Mechanism of ActionCytochrome P450 3A4 Inducers
Medical Subject Heading (MeSH) Categories for 016885
Suppliers and Packaging for NDA: 016885
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LYSODREN mitotane TABLET;ORAL 016885 NDA E.R. Squibb & Sons, L.L.C. 0015-3080 0015-3080-60 100 TABLET in 1 BOTTLE (0015-3080-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD: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
Fuji
Queensland Health
Federal Trade Commission
Cipla
Johnson and Johnson
US Department of Justice
Cerilliant
Accenture

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