Trazimera |
761081 |
002 |
351(k) Biosimilar |
trastuzumab-qyyp |
For Injection |
Intravenous |
150MG |
Single-Dose Vial |
2020/11/30
|
Pfizer Ireland Pharmaceuticals |
Rx |
Licensed |
trastuzumab |
Herceptin |
Danyelza |
761171 |
001 |
351(a) |
naxitamab-gqgk |
Injection |
Intravenous |
40MG/10ML (4MG/ML) |
Single-Dose Vial |
2020/11/25
|
Y-mABs Therapeutics, Inc |
Rx |
Licensed |
|
|
Inmazeb |
761169 |
001 |
351(a) |
atoltivimab, maftivimab, and odesivimab-ebgn |
Injection |
Intravenous |
241.7MG, 241.7MG, 241.7MG/14.5ML (16.67MG, 16.67MG, 16.67MG/ML) |
Single-Dose Vial |
2020/10/14
|
Regeneron Pharmaceuticals, Inc. |
Rx |
Licensed |
|
|
Ultomiris |
761108 |
002 |
351(a) |
ravulizumab-cwvz |
Injection |
Intravenous |
300MG/3ML (100MG/ML) |
Single-Dose Vial |
2020/10/09
|
Alexion Pharmaceuticals, Inc. |
Rx |
Licensed |
|
|
Ultomiris |
761108 |
003 |
351(a) |
ravulizumab-cwvz |
Injection |
Intravenous |
1100MG/11ML (100MG/ML) |
Single-Dose Vial |
2020/10/09
|
Alexion Pharmaceuticals, Inc. |
Rx |
Licensed |
|
|
Polivy |
761121 |
002 |
351(a) |
polatuzumab vedotin-piiq |
For Injection |
Intravenous |
30MG |
Single-Dose Vial |
2020/09/18
|
Genentech, Inc. |
Rx |
Licensed |
|
|
Trulicity |
125469 |
005 |
351(a) |
dulaglutide |
Injection |
Subcutaneous |
3MG/0.5ML |
Autoinjector |
2020/09/04
|
Eli Lilly and Company |
Rx |
Licensed |
|
|
Trulicity |
125469 |
006 |
351(a) |
dulaglutide |
Injection |
Subcutaneous |
4.5MG/0.5ML |
Autoinjector |
2020/09/04
|
Eli Lilly and Company |
Rx |
Licensed |
|
|
Sogroya |
761156 |
001 |
351(a) |
somapacitan-beco |
Injection |
Subcutaneous |
10MG/1.5ML (6.7MG/ML) |
Autoinjector |
2020/08/28
|
Novo Nordisk Inc. |
Rx |
Licensed |
|
|
Kesimpta |
125326 |
003 |
351(a) |
ofatumumab |
Injection |
Subcutaneous |
20MG/0.4ML |
Autoinjector |
2020/08/20
|
Novartis Pharmaceuticals Corporation |
Rx |
Licensed |
|
|
Kesimpta |
125326 |
004 |
351(a) |
ofatumumab |
Injection |
Subcutaneous |
20MG/0.4ML |
Pre-Filled Syringe |
2020/08/20
|
Novartis Pharmaceuticals Corporation |
Rx |
Licensed |
|
|
Enspryng |
761149 |
001 |
351(a) |
satralizumab-mwge |
Injection |
Subcutaneous |
120MG/ML |
Pre-Filled Syringe |
2020/08/14
|
Genentech, Inc. |
Rx |
Licensed |
|
|
Blenrep |
761158 |
001 |
351(a) |
belantamab mafodotin-blmf |
For Injection |
Intravenous |
100MG |
Single-Dose Vial |
2020/08/05
|
GlaxoSmithKline Intellectual Property Development Ltd. England |
Rx |
Licensed |
|
|
Monjuvi |
761163 |
001 |
351(a) |
tafasitamab-cxix |
For Injection |
Intravenous |
200MG |
Single-Dose Vial |
2020/07/31
|
MorphoSys US Inc. |
Rx |
Licensed |
|
|
Tecartus |
125703 |
001 |
351(a) |
Brexucabtagene Autoleucel |
For Injection |
Intravenous |
2x10^6 CAR-positive viable T cells per kg body weight |
Bag |
2020/07/24
|
Kite Pharma Inc. |
Rx |
Licensed |
|
|
Qwo |
761146 |
001 |
351(a) |
collagenase clostridium histolyticum-aaes |
For Injection |
Subcutaneous |
.92MG |
Single-Dose Vial |
2020/07/06
|
Endo Global Aesthetics Limited |
Rx |
Licensed |
|
|
Qwo |
761146 |
002 |
351(a) |
collagenase clostridium histolyticum-aaes |
For Injection |
Subcutaneous |
1.84MG |
Single-Dose Vial |
2020/07/06
|
Endo Global Aesthetics Limited |
Rx |
Licensed |
|
|
Hulio |
761154 |
001 |
351(k) Biosimilar |
adalimumab-fkjp |
Injection |
Subcutaneous |
40MG/0.8ML |
Autoinjector |
2020/07/06
|
Mylan Pharmaceuticals Inc. |
Rx |
Licensed |
adalimumab |
Humira |
Hulio |
761154 |
002 |
351(k) Biosimilar |
adalimumab-fkjp |
Injection |
Subcutaneous |
40MG/0.8ML |
Pre-Filled Syringe |
2020/07/06
|
Mylan Pharmaceuticals Inc. |
Rx |
Licensed |
adalimumab |
Humira |
Hulio |
761154 |
003 |
351(k) Biosimilar |
adalimumab-fkjp |
Injection |
Subcutaneous |
20MG/0.4ML |
Pre-Filled Syringe |
2020/07/06
|
Mylan Pharmaceuticals Inc. |
Rx |
Licensed |
adalimumab |
Humira |