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Last Updated: July 4, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 016848

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NDA 016848 describes ANADROL-50, which is a drug marketed by Mylan Speciality Lp and is included in one NDA. It is available from one supplier. Additional details are available on the ANADROL-50 profile page.

The generic ingredient in ANADROL-50 is oxymetholone. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the oxymetholone profile page.
Summary for 016848
Applicant:Mylan Speciality Lp
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 016848
Suppliers and Packaging for NDA: 016848
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ANADROL-50 oxymetholone TABLET;ORAL 016848 NDA Alaven Pharmaceutical LLC 68220-055 68220-055-10 1 BOTTLE in 1 CARTON (68220-055-10) > 100 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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