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Serving leading biopharmaceutical companies globally:

Express Scripts
US Department of Justice
Queensland Health
Boehringer Ingelheim

Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078033

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NDA 078033 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 nine 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 078033
Applicant:Upsher-smith Labs
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 078033
Suppliers and Packaging for NDA: 078033
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXANDROLONE oxandrolone TABLET;ORAL 078033 ANDA Upsher-Smith Laboratories, LLC 0245-0272 0245-0272-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0245-0272-01) > 1 TABLET in 1 BLISTER PACK (0245-0272-89)
OXANDROLONE oxandrolone TABLET;ORAL 078033 ANDA Upsher-Smith Laboratories, LLC 0245-0272 0245-0272-18 180 TABLET in 1 BOTTLE (0245-0272-18)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Mar 22, 2007TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

US Army
Daiichi Sankyo
Harvard Business School

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