Starjemza |
761419 |
001 |
351(k) Interchangeable |
ustekinumab-hmny |
Injection |
Subcutaneous |
45MG/0.5ML |
Pre-Filled Syringe |
2025/05/22
|
Bio-Thera Solutions, Ltd. |
Rx |
Licensed |
ustekinumab |
Stelara |
Starjemza |
761419 |
002 |
351(k) Interchangeable |
ustekinumab-hmny |
Injection |
Subcutaneous |
90MG/ML |
Pre-Filled Syringe |
2025/05/22
|
Bio-Thera Solutions, Ltd. |
Rx |
Licensed |
ustekinumab |
Stelara |
Starjemza |
761419 |
003 |
351(k) Interchangeable |
ustekinumab-hmny |
Injection |
Subcutaneous |
45MG/0.5ML |
Single-Dose Vial |
2025/05/22
|
Bio-Thera Solutions, Ltd. |
Rx |
Licensed |
ustekinumab |
Stelara |
Starjemza |
761419 |
004 |
351(k) Interchangeable |
ustekinumab-hmny |
Injection |
Intravenous |
130MG/26ML (5MG/ML) |
Single-Dose Vial |
2025/05/22
|
Bio-Thera Solutions, Ltd. |
Rx |
Licensed |
ustekinumab |
Stelara |
NUVAXOVID |
125817 |
001 |
351(a) |
COVID-19 Vaccine, Adjuvanted |
Injection |
Intramuscular |
5UG |
Pre-Filled Syringe |
2025/05/16
|
Novavax, Inc. |
Rx |
Licensed |
|
|
Emrelis |
761384 |
001 |
351(a) |
telisotuzumab vedotin-tllv |
Injection |
Intravenous |
20MG |
Single-Dose Vial |
2025/05/14
|
AbbVie Inc. |
Rx |
Licensed |
|
|
Emrelis |
761384 |
002 |
351(a) |
telisotuzumab vedotin-tllv |
Injection |
Intravenous |
100MG |
Single-Dose Vial |
2025/05/14
|
AbbVie Inc. |
Rx |
Licensed |
|
|
Humalog |
205747 |
002 |
351(a) |
insulin lispro |
Injection |
Subcutaneous |
600UNITS/3ML (200UNITS/ML) |
Autoinjector |
2025/05/07
|
Eli Lilly and Company |
Rx |
Licensed |
|
|
Imaavy |
761430 |
001 |
351(a) |
nipocalimab-aahu |
Injection |
Intravenous |
300MG/1.62ML (185MG/ML) |
Single-Dose Vial |
2025/04/29
|
Janssen Biotech, Inc. |
Rx |
Licensed |
|
|
Imaavy |
761430 |
002 |
351(a) |
nipocalimab-aahu |
Injection |
Intravenous |
1,200MG/6.5ML (185MG/ML) |
Single-Dose Vial |
2025/04/29
|
Janssen Biotech, Inc. |
Rx |
Licensed |
|
|
zevaskyn |
125807 |
001 |
351(a) |
Prademagene zamikeracel |
Cellular Sheet |
Topical |
41.25CM^2 |
Tray & Lid |
2025/04/28
|
Abeona Therapeutics Inc. |
Rx |
Licensed |
|
|
N/A |
761258 |
001 |
351(a) |
penpulimab-kcqx |
Injection |
Intravenous |
100MG/10ML (10MG/ML) |
Single-Dose Vial |
2025/04/23
|
Akeso Biopharma Co., Ltd. |
Rx |
Licensed |
|
|
Vyvgart Hytrulo |
761304 |
002 |
351(a) |
efgartigimod alfa and hyaluronidase-qvfc |
Injection |
Subcutaneous |
1,000MG/5ML;10,000UNITS/5ML (200MG/2,000UNITS/ML) |
Pre-Filled Syringe |
2025/04/10
|
Argenx BV |
Rx |
Licensed |
|
|
Jobevne |
761175 |
001 |
351(k) Biosimilar |
bevacizumab-nwgd |
Injection |
Intravenous |
100MG/4ML (25MG/ML) |
Single-Dose Vial |
2025/04/09
|
Biocon Biologics Inc. |
Rx |
Licensed |
bevacizumab |
Avastin |
Jobevne |
761175 |
002 |
351(k) Biosimilar |
bevacizumab-nwgd |
Injection |
Intravenous |
400MG/16ML (25MG/ML) |
Single-Dose Vial |
2025/04/09
|
Biocon Biologics Inc. |
Rx |
Licensed |
bevacizumab |
Avastin |
Jynneos |
125678 |
002 |
351(a) |
Smallpox and Mpox Vaccine, Live, Non-replicating |
For Injection |
Subcutaneous |
0.5-3.95 X 10E8 INF. U/.5ML |
Single-Dose Vial |
2025/03/21
|
Bavarian Nordic A/S |
Rx |
Licensed |
|
|
Otulfi |
761379 |
004 |
351(k) Interchangeable |
ustekinumab-aauz |
Injection |
Subcutaneous |
45MG/0.5ML |
Single-Dose Vial |
2025/03/21
|
Fresenius Kabi USA, LLC |
Rx |
Licensed |
ustekinumab |
Stelara |
Tyenne |
761449 |
001 |
351(k) Biosimilar |
tocilizumab-aazg |
Injection |
Subcutaneous |
162MG/0.9ML |
Pre-Filled Syringe |
2025/03/14
|
Fresenius Kabi USA, LLC |
Rx |
Licensed |
tocilizumab |
Actemra |
Tyenne |
761449 |
002 |
351(k) Biosimilar |
tocilizumab-aazg |
Injection |
Subcutaneous |
162MG/0.9ML |
Autoinjector |
2025/03/14
|
Fresenius Kabi USA, LLC |
Rx |
Licensed |
tocilizumab |
Actemra |
Omlyclo |
761399 |
001 |
351(k) Interchangeable |
omalizumab-igec |
Injection |
Subcutaneous |
75MG/0.5ML |
Pre-Filled Syringe |
2025/03/07
|
CELLTRION, Inc. |
Rx |
Licensed |
omalizumab |
Xolair |