oxandrolone
Oxandrolone Tablets, USP CIII
Approved
Approval ID
8e6af85f-e44e-4c47-8a1a-7c5cb7893167
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 1, 2020
Manufacturers
FDA
Upsher-Smith Laboratories, LLC
DUNS: 079111820
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
oxandrolone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0245-0272
Application NumberANDA078033
Product Classification
M
Marketing Category
C73584
G
Generic Name
oxandrolone
Product Specifications
Route of AdministrationORAL
Effective DateJuly 1, 2020
FDA Product Classification
INGREDIENTS (5)
oxandroloneActive
Quantity: 10 mg in 1 1
Code: 7H6TM3CT4L
Classification: ACTIB
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT