| Elrexfio |
761345 |
1 |
351(a) |
elranatamab-bcmm |
Injection |
Subcutaneous |
76MG/1.9ML (40MG/ML) |
Single-Dose Vial |
2023/08/14
|
Pfizer Inc. |
Rx |
Licensed |
|
|
| Elrexfio |
761345 |
2 |
351(a) |
elranatamab-bcmm |
Injection |
Subcutaneous |
44MG/1.1ML (40MG/ML) |
Single-Dose Vial |
2023/08/14
|
Pfizer Inc. |
Rx |
Licensed |
|
|
| Amjevita |
761024 |
5 |
351(k) Biosimilar |
adalimumab-atto |
Injection |
Subcutaneous |
20MG/0.2ML |
Pre-Filled Syringe |
2023/08/14
|
Amgen Inc. |
Rx |
Licensed |
adalimumab |
Humira |
| Amjevita |
761024 |
6 |
351(k) Biosimilar |
adalimumab-atto |
Injection |
Subcutaneous |
40MG/0.4ML |
Pre-Filled Syringe |
2023/08/14
|
Amgen Inc. |
Rx |
Licensed |
adalimumab |
Humira |
| Amjevita |
761024 |
7 |
351(k) Biosimilar |
adalimumab-atto |
Injection |
Subcutaneous |
80MG/0.8ML |
Pre-Filled Syringe |
2023/08/14
|
Amgen Inc. |
Rx |
Licensed |
adalimumab |
Humira |
| Amjevita |
761024 |
8 |
351(k) Biosimilar |
adalimumab-atto |
Injection |
Subcutaneous |
40MG/0.4ML |
Autoinjector |
2023/08/14
|
Amgen Inc. |
Rx |
Licensed |
adalimumab |
Humira |
| Amjevita |
761024 |
9 |
351(k) Biosimilar |
adalimumab-atto |
Injection |
Subcutaneous |
80MG/0.8ML |
Autoinjector |
2023/08/14
|
Amgen Inc. |
Rx |
Licensed |
adalimumab |
Humira |
| Talvey |
761342 |
1 |
351(a) |
talquetamab-tgvs |
Injection |
Subcutaneous |
3MG/1.5ML (2MG/ML) |
Single-Dose Vial |
2023/08/09
|
Janssen Biotech, Inc. |
Rx |
Licensed |
|
|
| Talvey |
761342 |
2 |
351(a) |
talquetamab-tgvs |
Injection |
Subcutaneous |
40MG/ML |
Single-Dose Vial |
2023/08/09
|
Janssen Biotech, Inc. |
Rx |
Licensed |
|
|
| Balfaxar |
125776 |
1 |
351(a) |
Prothrombin complex concentrate, human-lans |
For Injection |
Intravenous |
500IU |
Single-Dose Vial |
2023/07/21
|
Octapharma Pharmazeutika Produktionsges.m.b.H. |
Rx |
Licensed |
|
|
| CYFENDUS |
125761 |
1 |
351(a) |
Anthrax Vaccine Adsorbed, Adjuvanted |
Injection |
Intramuscular |
100UG/ML |
Multi-Dose Vial |
2023/07/20
|
Emergent Product Development Gaithersburg, Inc. |
Rx |
Licensed |
|
|
| Beyfortus |
761328 |
1 |
351(a) |
nirsevimab-alip |
Injection |
Intramuscular |
50MG/0.5ML |
Pre-Filled Syringe |
2023/07/17
|
AstraZeneca AB |
Rx |
Licensed |
|
|
| Roctavian |
125720 |
1 |
351(a) |
valoctocogene roxaparvovec-rvox |
Injection |
Intravenous |
16X 10E13GENOMES PER ML |
Single-Dose Vial |
2023/06/29
|
Biomarin Pharmaceutical Inc. |
Rx |
Licensed |
|
|
| Lantidra |
125734 |
1 |
351(a) |
donislecel-jujn |
Suspension |
Intravenous |
1X10E6EQUIVALENT ISLET NUMBER (EIN) |
Bag |
2023/06/28
|
CellTrans Inc. |
Rx |
Licensed |
|
|
| Ngenla |
761184 |
1 |
351(a) |
somatrogon-ghla |
Injection |
Subcutaneous |
24MG/1.2ML (20MG/ML) |
Autoinjector |
2023/06/27
|
Pfizer Ireland Pharmaceuticals |
Rx |
Licensed |
|
|
| Ngenla |
761184 |
2 |
351(a) |
somatrogon-ghla |
Injection |
Subcutaneous |
60MG/1.2ML (50MG/ML) |
Autoinjector |
2023/06/27
|
Pfizer Ireland Pharmaceuticals |
Rx |
Licensed |
|
|
| Rystiggo |
761286 |
1 |
351(a) |
rozanolixizumab-noli |
Injection |
Subcutaneous |
280MG/2ML (140MG/ML) |
Single-Dose Vial |
2023/06/26
|
UCB, Inc. |
Rx |
Licensed |
|
|
| ELEVIDYS |
125781 |
1 |
351(a) |
delandistrogene moxeparvovec-rokl |
Suspension |
Intravenous |
1.33 ×10E14 vector genomes (vg)/kg/bodyweight(bw) |
Single-Dose Vial |
2023/06/22
|
Sarepta Therapeutics, Inc. |
Rx |
Licensed |
|
|
| Fiasp |
208751 |
4 |
351(a) |
insulin aspart |
Injection |
Subcutaneous |
160UNITS/1.6ML (100UNITS/ML) |
Multi-Dose Cartridge |
2023/06/21
|
Novo Nordisk Inc. |
Rx |
Licensed |
|
|
| Vyvgart Hytrulo |
761304 |
1 |
351(a) |
efgartigimod alfa and hyaluronidase-qvfc |
Injection |
Subcutaneous |
1,008MG/5.6ML; 11,200UNITS/5.6ML (180MG/2,000UNITS/ML) |
Single-Dose Vial |
2023/06/20
|
Argenx BV |
Rx |
Licensed |
|
|
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