Oxandrolone
Oxandrolone Tablet, USP
Approved
Approval ID
a6f42739-5bfc-4b76-8795-e93fa58f3d29
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 7, 2022
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
Products 2
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 Code49884-302
Application NumberANDA077827
Product Classification
M
Marketing Category
C73584
G
Generic Name
oxandrolone
Product Specifications
Route of AdministrationORAL
Effective DateJuly 5, 2023
FDA Product Classification
INGREDIENTS (4)
OXANDROLONEActive
Quantity: 10 mg in 1 1
Code: 7H6TM3CT4L
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
oxandrolone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49884-301
Application NumberANDA077827
Product Classification
M
Marketing Category
C73584
G
Generic Name
oxandrolone
Product Specifications
Route of AdministrationORAL
Effective DateJuly 5, 2023
FDA Product Classification
INGREDIENTS (4)
OXANDROLONEActive
Quantity: 2.5 mg in 1 1
Code: 7H6TM3CT4L
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT