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Cipla
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Dow
US Department of Justice

Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076897

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NDA 076897 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 076897
Tradename:OXANDROLONE
Applicant:Sandoz
Ingredient:oxandrolone
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 076897

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength2.5MG
Approval Date:Dec 1, 2006TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG
Approval Date:Dec 1, 2006TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
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Daiichi Sankyo
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Deloitte
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Baxter

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