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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Queensland Health
Argus Health
Fish and Richardson
Boehringer Ingelheim

Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076761

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NDA 076761 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 076761

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

Medical Subject Heading (MeSH) Categories for 076761

Suppliers and Packaging for NDA: 076761

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXANDROLONE oxandrolone TABLET;ORAL 076761 ANDA Upsher-Smith Laboratories, LLC 0245-0271 0245-0271-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0245-0271-01) > 1 TABLET in 1 BLISTER PACK (0245-0271-89)
OXANDROLONE oxandrolone TABLET;ORAL 076761 ANDA Upsher-Smith Laboratories, LLC 0245-0271 0245-0271-11 100 TABLET in 1 BOTTLE (0245-0271-11)

Summary for product number 001

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

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Queensland Health
Boehringer Ingelheim

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