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Generated: April 23, 2019

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Details for New Drug Application (NDA): 016885

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NDA 016885 describes LYSODREN, which is a drug marketed by Laboratoire Hra and is included in one NDA. It is available from two suppliers. 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. Two suppliers are listed for this compound. Additional details are available on the mitotane profile page.
Summary for 016885
Applicant:Laboratoire Hra
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)
LYSODREN mitotane TABLET;ORAL 016885 NDA Laboratoire HRA Pharma 76336-080 76336-080-60 1 BOTTLE in 1 CARTON (76336-080-60) > 100 TABLET in 1 BOTTLE

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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