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FDA Approval

XYOSTED

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Antares Pharma, Inc.
DUNS: 085369585
Effective Date
January 4, 2024
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Testosterone Enanthate(100 mg in 0.5 mL)

Products3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

XYOSTED

Product Details

NDC Product Code
54436-200
Application Number
NDA209863
Marketing Category
NDA (C73594)
Route of Administration
SUBCUTANEOUS
Effective Date
August 1, 2023
SESAME OILInactive
Code: QX10HYY4QVClass: IACT
Code: 7Z6522T8N9Class: ACTIBQuantity: 100 mg in 0.5 mL

XYOSTED

Product Details

NDC Product Code
54436-275
Application Number
NDA209863
Marketing Category
NDA (C73594)
Route of Administration
SUBCUTANEOUS
Effective Date
August 1, 2023
SESAME OILInactive
Code: QX10HYY4QVClass: IACT
Code: 7Z6522T8N9Class: ACTIBQuantity: 75 mg in 0.5 mL

XYOSTED

Product Details

NDC Product Code
54436-250
Application Number
NDA209863
Marketing Category
NDA (C73594)
Route of Administration
SUBCUTANEOUS
Effective Date
August 1, 2023
Code: 7Z6522T8N9Class: ACTIBQuantity: 50 mg in 0.5 mL
SESAME OILInactive
Code: QX10HYY4QVClass: IACT
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