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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

Suppliers: see list1

Clinical Trials for: OXANDRIN

Oxandrolone for the Treatment of Bone Marrow Aplasia in Fanconi Anemia
Status: Completed Condition: Fanconi Anemia

Bioavailability Study of Oxandrolone Tablets Under Fasting Conditions
Status: Completed Condition: To Determine the Bioequivalence Under Fasting Conditions

Oxandrolone Compared With Megestrol in Preventing Weight Loss in Patients Receiving Chemotherapy for Cancer
Status: Completed Condition: Unspecified Adult Solid Tumor, Protocol Specific; Weight Changes

Pilot Study of the Safety and Efficacy of Oxandrolone in the Prevention and Treatment of Malnutrition in Infants
Status: Completed Condition: Malnutrition

Pilot Study of Goal-Directed Iron Supplementation +/- Oxandrolone for Functional Iron Deficiency of Critical Illness
Status: Not yet recruiting Condition: Functional Iron Deficiency; Trauma; Anemia

Oxandrolone to Heal Pressure Ulcers
Status: Terminated Condition: Pressure Ulcer

The Use of Anabolic Steroids to Improve Function After Spinal Cord Injury
Status: Completed Condition: Spinal Cord Injury

Oxandrolone Compared With a Placebo on Growth Rate in Girls With Growth Hormone-Treated Turner's Syndrome
Status: Completed Condition: Turner's Syndrome

Study of Albuterol and Oxandrolone in Patients With Facioscapulohumeral Dystrophy (FSHD)
Status: Completed Condition: Muscular Dystrophies

Assessment of the Treatment of Severely Burned With Anabolic Agents on Clinical Outcomes, Recovery and Rehabilitation
Status: Recruiting Condition: Burns

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Crealta Pharms Llc
TABLET;ORAL013718-001Approved Prior to Jan 1, 1982RXNo5,872,147<disabled><disabled>
Crealta Pharms Llc
TABLET;ORAL013718-002Nov 5, 2001RXYes5,872,147<disabled><disabled>
Crealta Pharms Llc
TABLET;ORAL013718-002Nov 5, 2001RXYes6,828,313<disabled><disabled>
Crealta Pharms Llc
TABLET;ORAL013718-002Nov 5, 2001RXYes6,090,799<disabled><disabled>
Crealta Pharms Llc
TABLET;ORAL013718-002Nov 5, 2001RXYes6,576,659<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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Preferred citation:

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

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