Application 213953
- Type
- NDA
- Sponsor
- MARIUS PHARMACEUTICALS, LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | KYZATREX | TESTOSTERONE UNDECANOATE | CAPSULE; ORAL | 100MG | No | No |
| 002 | KYZATREX | TESTOSTERONE UNDECANOATE | CAPSULE; ORAL | 150MG | No | No |
| 003 | KYZATREX | TESTOSTERONE UNDECANOATE | CAPSULE; ORAL | 200MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 80603-101 | Kyzatrex | TESTOSTERONE UNDECANOATE | Marius Pharmaceuticals | NDA | Current |
| 80603-101 | Kyzatrex | TESTOSTERONE UNDECANOATE | Marius Pharmaceuticals | NDA | Current |
| 80603-101 | Kyzatrex | TESTOSTERONE UNDECANOATE | Marius Pharmaceuticals | NDA | Current |
| 80603-101 | Kyzatrex | TESTOSTERONE UNDECANOATE | Marius Pharmaceuticals | NDA | Current |
| 80603-101 | Kyzatrex | TESTOSTERONE UNDECANOATE | Marius Pharmaceuticals | NDA | Current |
| 80603-101 | Kyzatrex | TESTOSTERONE UNDECANOATE | Marius Pharmaceuticals | NDA | Current |
| 80603-103 | Kyzatrex | TESTOSTERONE UNDECANOATE | Marius Pharmaceuticals | NDA | Current |
| 80603-103 | Kyzatrex | TESTOSTERONE UNDECANOATE | Marius Pharmaceuticals | NDA | Current |
| 80603-103 | Kyzatrex | TESTOSTERONE UNDECANOATE | Marius Pharmaceuticals | NDA | Current |
| 80603-103 | Kyzatrex | TESTOSTERONE UNDECANOATE | Marius Pharmaceuticals | NDA | Current |
| 80603-103 | Kyzatrex | TESTOSTERONE UNDECANOATE | Marius Pharmaceuticals | NDA | Current |
| 80603-103 | Kyzatrex | TESTOSTERONE UNDECANOATE | Marius Pharmaceuticals | NDA | Current |
| 80603-105 | Kyzatrex | TESTOSTERONE UNDECANOATE | Marius Pharmaceuticals | NDA | Current |
| 80603-105 | Kyzatrex | TESTOSTERONE UNDECANOATE | Marius Pharmaceuticals | NDA | Current |
| 80603-105 | Kyzatrex | TESTOSTERONE UNDECANOATE | Marius Pharmaceuticals | NDA | Current |
| 80603-105 | Kyzatrex | TESTOSTERONE UNDECANOATE | Marius Pharmaceuticals | NDA | Current |
| 80603-105 | Kyzatrex | TESTOSTERONE UNDECANOATE | Marius Pharmaceuticals | NDA | Current |
| 80603-105 | Kyzatrex | TESTOSTERONE UNDECANOATE | Marius Pharmaceuticals | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 82866 | SUPPL | 2025-07-15 |
| 82846 | SUPPL | 2025-07-14 |
| 82845 | SUPPL | 2025-07-14 |
| 72987 | ORIG | 2022-12-21 |
| 71659 | ORIG | 2022-07-28 |
| 71654 | ORIG | 2022-07-28 |