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Generated: May 26, 2017

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Details for New Drug Application (NDA): 078033

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NDA 078033 describes OXANDROLONE, which is a drug marketed by Par Pharm, Upsher Smith, Roxane, and Sandoz, and is included in five NDAs. It is available from four 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. Four suppliers are listed for this compound. Additional details are available on the oxandrolone profile page.

Summary for NDA: 078033

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 078033

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 078033 ANDA Upsher-Smith Laboratories, Inc. 0245-0272 0245-0272-01 10 BLISTER PACK in 1 BOX, UNIT-DOSE (0245-0272-01) > 10 TABLET in 1 BLISTER PACK (0245-0272-89)
TABLET;ORAL 078033 ANDA Upsher-Smith Laboratories, Inc. 0245-0272 0245-0272-06 60 TABLET in 1 BOTTLE (0245-0272-06)

Summary for product number 001

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

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