Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209863

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XYOSTED (AUTOINJECTOR) (TESTOSTERONE ENANTHATE)
50MG/0.5ML (50MG/0.5ML)
Marketing Status: Prescription

Active Ingredient: TESTOSTERONE ENANTHATE
Proprietary Name: XYOSTED (AUTOINJECTOR)
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 50MG/0.5ML (50MG/0.5ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209863
Product Number: 001
Approval Date: Sep 28, 2018
Applicant Holder Full Name: ANTARES PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

XYOSTED (AUTOINJECTOR) (TESTOSTERONE ENANTHATE)
75MG/0.5ML (75MG/0.5ML)
Marketing Status: Prescription

Active Ingredient: TESTOSTERONE ENANTHATE
Proprietary Name: XYOSTED (AUTOINJECTOR)
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 75MG/0.5ML (75MG/0.5ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209863
Product Number: 002
Approval Date: Sep 28, 2018
Applicant Holder Full Name: ANTARES PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

XYOSTED (AUTOINJECTOR) (TESTOSTERONE ENANTHATE)
100MG/0.5ML (100MG/0.5ML)
Marketing Status: Prescription

Active Ingredient: TESTOSTERONE ENANTHATE
Proprietary Name: XYOSTED (AUTOINJECTOR)
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 100MG/0.5ML (100MG/0.5ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209863
Product Number: 003
Approval Date: Sep 28, 2018
Applicant Holder Full Name: ANTARES PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information