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: CLARUS THERAPEUTICS 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: CLARUS THERAPEUTICS 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: CLARUS THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English