Suppliers and packages for generic ingredient: testosterone undecanoate
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testosterone undecanoate
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Tolmar | JATENZO | testosterone undecanoate | CAPSULE;ORAL | 206089 | NDA | TOLMAR Inc. | 69087-158-12 | 12 BOTTLE, PLASTIC in 1 BOX (69087-158-12) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC | 2019-08-01 |
| Tolmar | JATENZO | testosterone undecanoate | CAPSULE;ORAL | 206089 | NDA | TOLMAR Inc. | 69087-198-12 | 12 BOTTLE, PLASTIC in 1 BOX (69087-198-12) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC | 2019-08-01 |
| Tolmar | JATENZO | testosterone undecanoate | CAPSULE;ORAL | 206089 | NDA | TOLMAR Inc. | 69087-237-12 | 12 BOTTLE, PLASTIC in 1 BOX (69087-237-12) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC | 2019-08-01 |
| Marius Pharms Llc | KYZATREX | testosterone undecanoate | CAPSULE;ORAL | 213953 | NDA AUTHORIZED GENERIC | Trifluent Pharma LLC | 73352-105-22 | 120 CAPSULE in 1 BOTTLE (73352-105-22) | 2024-09-11 |
| Marius Pharms Llc | KYZATREX | testosterone undecanoate | CAPSULE;ORAL | 213953 | NDA | Marius Pharmaceuticals | 80603-101-11 | 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-101-11) | 2022-07-27 |
| Marius Pharms Llc | KYZATREX | testosterone undecanoate | CAPSULE;ORAL | 213953 | NDA | Marius Pharmaceuticals | 80603-101-22 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-101-22) | 2022-07-27 |
| Marius Pharms Llc | KYZATREX | testosterone undecanoate | CAPSULE;ORAL | 213953 | NDA | Marius Pharmaceuticals | 80603-103-11 | 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-103-11) | 2022-07-27 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
