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Oxandrolone

Generic Name
Oxandrolone
Brand Names
Oxandrin
Drug Type
Small Molecule
Chemical Formula
C19H30O3
CAS Number
53-39-4
Unique Ingredient Identifier
7H6TM3CT4L

Overview

A synthetic hormone with anabolic and androgenic properties.

Background

A synthetic hormone with anabolic and androgenic properties.

Indication

Use to promote weight gain after weight loss following extensive surgery.

Associated Conditions

  • Amino acid catabolism disorder
  • Pain

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
Subdermal Implant-bioabsorbable Oxandrolone Pellet For Rehabilitation Following Anterior Cruciate Ligament (ACL) Surgical Reconstruction
2025/05/16
NCT06974526
Phase 2
Not yet recruiting
Science Valley Research Institute
Oxandrolone Multiligament Knee
2023/06/07
NCT05893069
Phase 4
Suspended
George F. Hatch
Placebo Versus Oxandrolone Supplementation in Trauma
2022/08/26
NCT05516849
Phase 3
Withdrawn
Sunnybrook Health Sciences Centre
Use of Oxandrolone to Promote Growth in Infants With HLHS
2019/09/16
NCT04090697
Phase 1
Terminated
Carelon Research
Oxandrolone in Healthy Adults: A Relative Bioavailability Study
2017/07/14
NCT03218631
Phase 1
Completed
University of Utah
Oxandrolone Rotator Cuff Trial
2017/03/27
NCT03091075
Not Applicable
Active, not recruiting
University of Southern California
RCT of Goal-directed Iron Supplementation of Anemic, Critically Ill Trauma Patients, With and Without Oxandrolone
2014/01/28
NCT02047552
Phase 2
Withdrawn
Denver Health and Hospital Authority
Pilot Study of the Safety and Efficacy of Oxandrolone in the Prevention and Treatment of Malnutrition in Infants
2010/01/13
NCT01048632
Phase 1
Completed
University of Utah
Assessment of the Treatment of Severely Burned With Anabolic Agents on Clinical Outcomes, Recovery and Rehabilitation
2008/05/12
NCT00675714
Phase 2
Terminated
The University of Texas Medical Branch, Galveston
Assessment of Mechanisms of Improved Wound Healing
2008/05/07
NCT00673309
Phase 2
Completed
The University of Texas Medical Branch, Galveston

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Oxandrolone
Upsher-Smith Laboratories, LLC
0245-0271
ORAL
2.5 mg in 1 1
7/1/2020
Oxandrolone
Bryant Ranch Prepack
63629-7603
ORAL
2.5 mg in 1 1
5/6/2022
oxandrolone
Upsher-Smith Laboratories, LLC
0245-0272
ORAL
10 mg in 1 1
7/1/2020
Oxandrolone
Par Pharmaceutical, Inc.
49884-302
ORAL
10 mg in 1 1
7/5/2023
Oxandrolone
Par Pharmaceutical, Inc.
49884-301
ORAL
2.5 mg in 1 1
7/5/2023

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.
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