Details for New Drug Application (NDA): 213953
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NDA 213953 describes KYZATREX, which is a drug marketed by Marius and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the KYZATREX profile page.
The generic ingredient in KYZATREX is testosterone undecanoate. There are sixty-nine drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the testosterone undecanoate profile page.
The generic ingredient in KYZATREX is testosterone undecanoate. There are sixty-nine drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the testosterone undecanoate profile page.
Summary for 213953
| Tradename: | KYZATREX |
| Applicant: | Marius |
| Ingredient: | testosterone undecanoate |
| Patents: | 6 |
Pharmacology for NDA: 213953
| Mechanism of Action | Androgen Receptor Agonists |
Suppliers and Packaging for NDA: 213953
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KYZATREX | testosterone undecanoate | CAPSULE;ORAL | 213953 | NDA | Marius Pharmaceuticals | 80603-103 | 80603-103-11 | 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-103-11) |
| KYZATREX | testosterone undecanoate | CAPSULE;ORAL | 213953 | NDA | Marius Pharmaceuticals | 80603-103 | 80603-103-22 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-103-22) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | Jul 27, 2022 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 27, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | 10,576,089 | Patent Expiration: | Dec 31, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF TREATING TESTOSTERONE DEFICIENCY | ||||||||
| Patent: | 10,576,090 | Patent Expiration: | Dec 31, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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