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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Federal Trade Commission
Mallinckrodt
Medtronic
Harvard Business School
Boehringer Ingelheim
Fuji
QuintilesIMS
US Army

Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077249

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NDA 077249 describes OXANDROLONE, which is a drug marketed by Par Pharm, Roxane, Sandoz, and Upsher-smith Labs, and is included in five NDAs. It is available from three suppliers. Additional details are available on the OXANDROLONE profile page.

The generic ingredient in OXANDROLONE is oxandrolone. There are ten drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the oxandrolone profile page.
Summary for 077249
Tradename:OXANDROLONE
Applicant:Roxane
Ingredient:oxandrolone
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 077249

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength2.5MG
Approval Date:Jul 10, 2007TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG
Approval Date:Jul 10, 2007TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson
Merck
Julphar
Medtronic
QuintilesIMS
Cantor Fitzgerald
Queensland Health
Mallinckrodt

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