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Boehringer Ingelheim
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Generated: May 22, 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 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 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 N 0245-0272-01
OXANDROLONE oxandrolone TABLET;ORAL 078033 ANDA Upsher-Smith Laboratories, LLC 0245-0272 N 0245-0272-06

Profile for product number 001

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

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