Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Pharmaceutics Internatonal Inc.
Upsher-Smith Laboratories, LLC
878265586
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Oxandrolone
Product Details
NDC Product Code
0245-0271Application Number
ANDA076761Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
July 1, 2020anhydrous lactoseInactive
Code: 3SY5LH9PMKClass: IACT
starch, cornInactive
Code: O8232NY3SJClass: IACT
OxandroloneActive
Code: 7H6TM3CT4LClass: ACTIBQuantity: 2.5 mg in 1 1
hypromellose, unspecifiedInactive
Code: 3NXW29V3WOClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT