Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 206089

Expand all

JATENZO (TESTOSTERONE UNDECANOATE)
158MG
Marketing Status: Prescription

Active Ingredient: TESTOSTERONE UNDECANOATE
Proprietary Name: JATENZO
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 158MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N206089
Product Number: 001
Approval Date: Mar 27, 2019
Applicant Holder Full Name: TOLMAR INC
Marketing Status:  Prescription
Patent and Exclusivity Information

JATENZO (TESTOSTERONE UNDECANOATE)
198MG
Marketing Status: Prescription

Active Ingredient: TESTOSTERONE UNDECANOATE
Proprietary Name: JATENZO
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 198MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N206089
Product Number: 002
Approval Date: Mar 27, 2019
Applicant Holder Full Name: TOLMAR INC
Marketing Status:  Prescription
Patent and Exclusivity Information

JATENZO (TESTOSTERONE UNDECANOATE)
237MG
Marketing Status: Prescription

Active Ingredient: TESTOSTERONE UNDECANOATE
Proprietary Name: JATENZO
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 237MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N206089
Product Number: 003
Approval Date: Mar 27, 2019
Applicant Holder Full Name: TOLMAR INC
Marketing Status:  Prescription
Patent and Exclusivity Information