Simlandi |
761299 |
003 |
351(k) Biosimilar |
adalimumab-ryvk |
Injection |
Subcutaneous |
20MG/0.2ML |
Pre-Filled Syringe |
2024/06/26
|
Alvotech USA Inc. |
Rx |
Licensed |
adalimumab |
Humira |
Simlandi |
761299 |
004 |
351(k) Biosimilar |
adalimumab-ryvk |
Injection |
Subcutaneous |
80MG/0.8ML |
Pre-Filled Syringe |
2024/06/26
|
Alvotech USA Inc. |
Rx |
Licensed |
adalimumab |
Humira |
Piasky |
761388 |
001 |
351(a) |
crovalimab-akkz |
Injection |
Intravenous, Subcutaneous |
340MG/2ML (170MG/ML) |
Single-Dose Vial |
2024/06/20
|
Genentech, Inc. |
Rx |
Licensed |
|
|
Sevenfact |
125641 |
003 |
351(a) |
coagulation factor VIIa (recombinant)-jncw |
Injection |
Intravenous |
2MG |
Single-Dose Vial |
2024/06/20
|
Laboratoire Francais du Fractionnement et des Biotechnologies S.A. |
Rx |
Licensed |
|
|
CAPVAXIVE |
125814 |
001 |
351(a) |
Pneumococcal 21-valent Conjugate Vaccine |
Injection |
Intramuscular |
84UG/.5ML |
Pre-Filled Syringe |
2024/06/17
|
Merck Sharp & Dohme LLC |
Rx |
Licensed |
|
|
YIMMUGO |
125810 |
001 |
351(a) |
immune globulin intravenous, human-dira |
For Injection |
Intravenous |
5G/50ML |
Single-Dose Vial |
2024/06/13
|
YIMMUGO |
Rx |
Licensed |
|
|
YIMMUGO |
125810 |
002 |
351(a) |
immune globulin intravenous, human-dira |
For Injection |
Intravenous |
10G/100ML |
Single-Dose Vial |
2024/06/13
|
YIMMUGO |
Rx |
Licensed |
|
|
YIMMUGO |
125810 |
003 |
351(a) |
immune globulin intravenous, human-dira |
For Injection |
Intravenous |
20G/200ML |
Single-Dose Vial |
2024/06/13
|
YIMMUGO |
Rx |
Licensed |
|
|
Adbry |
761180 |
002 |
351(a) |
tralokinumab-ldrm |
Injection |
Subcutaneous |
300MG/2ML |
Autoinjector |
2024/06/12
|
LEO Pharma A/S |
Rx |
Licensed |
|
|
mresvia |
125796 |
001 |
351(a) |
Respiratory Syncytial Virus Vaccine, mRNA (mRNA-1345) |
For Injection |
Intramuscular |
50UG/.5ML |
Pre-Filled Syringe |
2024/05/31
|
ModernaTX, Inc. |
Rx |
Licensed |
|
|
Bkemv |
761333 |
001 |
351(k) Interchangeable |
eculizumab-aeeb |
Injection |
Intravenous |
300MG/30ML (10MG/ML) |
Single-Dose Vial |
2024/05/28
|
Amgen Inc. |
Rx |
Licensed |
eculizumab |
Soliris |
Yesafili |
761274 |
001 |
351(k) Interchangeable |
aflibercept-jbvf |
Injection |
Intravitreal |
2MG/0.05ML |
Single-Dose Vial |
2024/05/20
|
Biocon Biologics Inc. |
Rx |
Licensed |
aflibercept |
Eylea |
Opuviz |
761350 |
001 |
351(k) Interchangeable |
aflibercept-yszy |
Injection |
Intravitreal |
2MG/0.05ML |
Single-Dose Vial |
2024/05/20
|
Samsung Bioepis Co., Ltd. |
Rx |
Licensed |
aflibercept |
Eylea |
Elfabrio |
761161 |
002 |
351(a) |
pegunigalsidase alfa-iwxj |
Injection |
Intravenous |
5MG/2.5ML |
Single-Dose Vial |
2024/05/17
|
Chiesi Farmaceutici S.p.A. |
Rx |
Licensed |
|
|
Imdelltra |
761344 |
001 |
351(a) |
tarlatamab-dlle |
Injection |
Intravenous |
1MG |
Single-Dose Vial |
2024/05/16
|
Amgen Inc. |
Rx |
Licensed |
|
|
Imdelltra |
761344 |
002 |
351(a) |
tarlatamab-dlle |
Injection |
Intravenous |
10MG |
Single-Dose Vial |
2024/05/16
|
Amgen Inc. |
Rx |
Licensed |
|
|
Eticovo |
761066 |
003 |
351(k) Biosimilar |
etanercept-ykro |
Injection |
Subcutaneous |
50MG/ML |
Autoinjector |
2024/05/03
|
Samsung Bioepis Co., Ltd. |
Disc |
Licensed |
etanercept |
Enbrel |
Cyltezo |
761058 |
005 |
351(k) Biosimilar |
adalimumab-adbm |
Injection |
Subcutaneous |
40MG/0.4ML |
Pre-Filled Syringe |
2024/04/30
|
Boehringer Ingelheim Pharmaceuticals, Inc. |
Rx |
Licensed |
adalimumab |
Humira |
Cyltezo |
761058 |
006 |
351(k) Biosimilar |
adalimumab-adbm |
Injection |
Subcutaneous |
40MG/0.4ML |
Autoinjector |
2024/04/30
|
Boehringer Ingelheim Pharmaceuticals, Inc. |
Rx |
Licensed |
adalimumab |
Humira |
Hercessi |
761346 |
001 |
351(k) Biosimilar |
trastuzumab-strf |
For Injection |
Intravenous |
150MG |
Single-Dose Vial |
2024/04/25
|
Accord BioPharma Inc. |
Rx |
Licensed |
trastuzumab |
Herceptin |