Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Par Pharmaceutical Inc.
092733690
Products2
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
49884-302Application Number
ANDA077827Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
July 5, 2023OxandroloneActive
Code: 7H6TM3CT4LClass: ACTIBQuantity: 10 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Oxandrolone
Product Details
NDC Product Code
49884-301Application Number
ANDA077827Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
July 5, 2023OxandroloneActive
Code: 7H6TM3CT4LClass: ACTIBQuantity: 2.5 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT