| Alyglo |
125743 |
1 |
351(a) |
immune globulin intravenous, human-stwk |
Injection |
Intravenous |
10% 100MG/ML |
Single-Dose Vial |
2023/12/15
|
GC Biopharma Corp. |
Rx |
Licensed |
|
|
| Casgevy |
125787 |
1 |
351(a) |
Exagamglogene autotemcel |
Suspension |
Intravenous |
4-13 × 10^6 CELL/ML |
Single-Dose Vial |
2023/12/08
|
Vertex Pharmaceuticals Inc |
Rx |
Licensed |
|
|
| LYFGENIA |
125788 |
1 |
351(a) |
lovotibeglogene autotemcel |
Suspension |
Intravenous |
1.7-20x10^6CELL/ML |
Bag |
2023/12/08
|
bluebird bio Inc. |
Rx |
Licensed |
|
|
| Avzivi |
761198 |
1 |
351(k) Biosimilar |
bevacizumab-tnjn |
Injection |
Intravenous |
100MG/4ML (25MG/ML) |
Single-Dose Vial |
2023/12/06
|
Bio-Thera Solutions, Ltd. |
Rx |
Licensed |
bevacizumab |
Avastin |
| Avzivi |
761198 |
2 |
351(k) Biosimilar |
bevacizumab-tnjn |
Injection |
Intravenous |
400MG/16ML (25MG/ML) |
Single-Dose Vial |
2023/12/06
|
Bio-Thera Solutions, Ltd. |
Rx |
Licensed |
bevacizumab |
Avastin |
| Ryzneuta |
761134 |
1 |
351(a) |
efbemalenograstim alfa-vuxw |
Injection |
Subcutaneous |
20MG/ML |
Pre-Filled Syringe |
2023/11/16
|
Evive Biotechnology Singapore PTE. LTD. |
Rx |
Licensed |
|
|
| IXCHIQ |
125777 |
1 |
351(a) |
Chikungunya Vaccine, Live |
For Injection |
Intramuscular |
3.0 log10 TCID |
Single-Dose Vial |
2023/11/09
|
Valneva Austria GmbH |
Rx |
Licensed |
|
|
| ADZYNMA |
125795 |
1 |
351(a) |
ADAMTS13, recombinant-krhn |
For Injection |
Intravenous |
500IU |
Single-Dose Vial |
2023/11/09
|
Takeda Pharmaceuticals U.S.A., Inc. |
Rx |
Licensed |
|
|
| ADZYNMA |
125795 |
2 |
351(a) |
ADAMTS13, recombinant-krhn |
For Injection |
Intravenous |
1500IU |
Single-Dose Vial |
2023/11/09
|
Takeda Pharmaceuticals U.S.A., Inc. |
Rx |
Licensed |
|
|
| Wezlana |
761331 |
1 |
351(k) Interchangeable |
ustekinumab-auub |
Injection |
Intravenous |
130MG/26ML (5MG/ML) |
Single-Dose Vial |
2023/10/31
|
Amgen Inc. |
Rx |
Licensed |
ustekinumab |
Stelara |
| Wezlana |
761285 |
1 |
351(k) Interchangeable |
ustekinumab-auub |
Injection |
Subcutaneous |
45MG/0.5ML |
Pre-Filled Syringe |
2023/10/31
|
Amgen Inc. |
Rx |
Licensed |
ustekinumab |
Stelara |
| Wezlana |
761285 |
2 |
351(k) Interchangeable |
ustekinumab-auub |
Injection |
Subcutaneous |
90MG/ML |
Pre-Filled Syringe |
2023/10/31
|
Amgen Inc. |
Rx |
Licensed |
ustekinumab |
Stelara |
| Wezlana |
761285 |
3 |
351(k) Interchangeable |
ustekinumab-auub |
Injection |
Subcutaneous |
45MG/0.5ML |
Single-Dose Vial |
2023/10/31
|
Amgen Inc. |
Rx |
Licensed |
ustekinumab |
Stelara |
| Loqtorzi |
761240 |
1 |
351(a) |
toripalimab-tpzi |
Injection |
Intravenous |
240MG/6ML (40MG/ML) |
Single-Dose Vial |
2023/10/27
|
Coherus BioSciences, Inc. |
Rx |
Licensed |
|
|
| Zenpep |
022210 |
8 |
351(a) |
pancrelipase |
Capsule, Delayed Release |
Oral |
60,000USP UNITS; 189,600USP UNITS; 252,600USP UNITS |
|
2023/10/27
|
Zenpep, LLC |
Rx |
Licensed |
|
|
| Omvoh |
761279 |
1 |
351(a) |
mirikizumab-mrkz |
Injection |
Intravenous |
300MG/15ML (20MG/ML) |
Single-Dose Vial |
2023/10/26
|
Eli Lilly and Company |
Rx |
Licensed |
|
|
| Omvoh |
761279 |
2 |
351(a) |
mirikizumab-mrkz |
Injection |
Subcutaneous |
100MG/ML |
Pre-Filled Syringe |
2023/10/26
|
Eli Lilly and Company |
Rx |
Licensed |
|
|
| Zymfentra |
761358 |
1 |
351(a) |
infliximab-dyyb |
Injection |
Subcutaneous |
120MG/ML |
Pre-Filled Syringe |
2023/10/20
|
CELLTRION, Inc. |
Rx |
Licensed |
|
|
| Zymfentra |
761358 |
2 |
351(a) |
infliximab-dyyb |
Injection |
Subcutaneous |
120MG/ML |
Autoinjector |
2023/10/20
|
CELLTRION, Inc. |
Rx |
Licensed |
|
|
| PENBRAYA |
125770 |
1 |
351(a) |
Meningococcal Groups A, B, C, W and Y Vaccine |
Injection |
Intramuscular |
5UG |
Pre-Filled Syringe |
2023/10/20
|
Pfizer Ireland Pharmaceuticals |
Rx |
Licensed |
|
|
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