NDC 80603-105

Kyzatrex

Testosterone Undecanoate

Kyzatrex is a Oral Capsule, Liquid Filled in the Human Prescription Drug category. It is labeled and distributed by Marius Pharmaceuticals. The primary component is Testosterone Undecanoate.

Product ID80603-105_3b31326b-606a-4fc9-9432-00775cfd05af
NDC80603-105
Product TypeHuman Prescription Drug
Proprietary NameKyzatrex
Generic NameTestosterone Undecanoate
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2022-07-27
Marketing CategoryNDA /
Application NumberNDA213953
Labeler NameMarius Pharmaceuticals
Substance NameTESTOSTERONE UNDECANOATE
Active Ingredient Strength200 mg/1
Pharm ClassesAndrogen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 80603-105-11

90 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-105-11)
Marketing Start Date2022-07-27
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Kyzatrex" or generic name "Testosterone Undecanoate"

NDCBrand NameGeneric Name
80603-101KyzatrexTESTOSTERONE UNDECANOATE
80603-103KyzatrexTESTOSTERONE UNDECANOATE
80603-105KyzatrexTESTOSTERONE UNDECANOATE
67979-511Aveedtestosterone undecanoate
69087-158Jatenzotestosterone undecanoate
69087-198Jatenzotestosterone undecanoate
69087-237Jatenzotestosterone undecanoate
54436-112Tlandotestosterone undecanoate

Trademark Results [Kyzatrex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
KYZATREX
KYZATREX
88826033 not registered Live/Pending
Marius Pharmaceuticals LLC
2020-03-09

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.