Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 213953

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KYZATREX (TESTOSTERONE UNDECANOATE)
100MG
Marketing Status: Prescription

Active Ingredient: TESTOSTERONE UNDECANOATE
Proprietary Name: KYZATREX
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213953
Product Number: 001
Approval Date: Jul 27, 2022
Applicant Holder Full Name: MARIUS PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

KYZATREX (TESTOSTERONE UNDECANOATE)
150MG
Marketing Status: Prescription

Active Ingredient: TESTOSTERONE UNDECANOATE
Proprietary Name: KYZATREX
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 150MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213953
Product Number: 002
Approval Date: Jul 27, 2022
Applicant Holder Full Name: MARIUS PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

KYZATREX (TESTOSTERONE UNDECANOATE)
200MG
Marketing Status: Prescription

Active Ingredient: TESTOSTERONE UNDECANOATE
Proprietary Name: KYZATREX
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213953
Product Number: 003
Approval Date: Jul 27, 2022
Applicant Holder Full Name: MARIUS PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information