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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Fish and Richardson
Daiichi Sankyo
Cantor Fitzgerald

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 016885

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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
Applicant:Bristol Myers Squibb
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

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Queensland Health
Federal Trade Commission
Johnson and Johnson
US Department of Justice

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