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Profile for Tradename: OXANDRIN

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Oxandrin is a drug marketed by Crealta Pharms Llc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in OXANDRIN is oxandrolone. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the oxandrolone profile page.

Summary for Tradename: OXANDRIN

Patents:4
Applicants:1
NDAs:1
Suppliers: see list1

Clinical Trials for: OXANDRIN

Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Crealta Pharms Llc
OXANDRIN
oxandrolone
TABLET;ORAL013718Approved Prior to Jan 1, 1982RXNo5,872,147<disabled><disabled>
Crealta Pharms Llc
OXANDRIN
oxandrolone
TABLET;ORAL013718Nov 5, 2001RXYes5,872,147<disabled><disabled>
Crealta Pharms Llc
OXANDRIN
oxandrolone
TABLET;ORAL013718Approved Prior to Jan 1, 1982RXNo6,828,313<disabled><disabled>
Crealta Pharms Llc
OXANDRIN
oxandrolone
TABLET;ORAL013718Nov 5, 2001RXYes6,576,659<disabled><disabled>
Crealta Pharms Llc
OXANDRIN
oxandrolone
TABLET;ORAL013718Nov 5, 2001RXYes6,090,799<disabled><disabled>
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Paragraph IV activity for: OXANDRIN

Drugname Dosage Strength RLD Submissiondate
oxandroloneTablets2.5 mg and 10 mgOxandrin6/19/2006
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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