← FDA DRUG APPROVALS

FDA NDA · NDA209863

XYOSTED

testosterone enanthate

Sponsor: ANTARES PHARMA INC

APPLICATION
NDA209863
TYPE
NDA
ORIGINAL APPROVAL
2018-09-28
LATEST ACTION
2025-07-11
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

XYOSTED (AUTOINJECTOR) · ReferencePrescription
TESTOSTERONE ENANTHATE 100MG/0.5ML (100MG/0.5ML) · SOLUTION · SUBCUTANEOUS
XYOSTED (AUTOINJECTOR) · ReferencePrescription
TESTOSTERONE ENANTHATE 50MG/0.5ML (50MG/0.5ML) · SOLUTION · SUBCUTANEOUS
XYOSTED (AUTOINJECTOR) · ReferencePrescription
TESTOSTERONE ENANTHATE 75MG/0.5ML (75MG/0.5ML) · SOLUTION · SUBCUTANEOUS

Approval history

2025-07-11Labeling · Supplement 20 · standard — Label ↗AP
2019-11-19Labeling · Supplement 2 · standard — Letter ↗AP
2018-09-28Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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