Documents
Application Sponsors
| BLA 125370 | HUMAN GENOME SCIENCES INC. | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE; INJECTION | 120MG | 0 | BENLYSTA | BELIMUMAB |
| 002 | INJECTABLE; INJECTION | 400MG | 0 | BENLYSTA | BELIMUMAB |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2011-03-09 | PRIORITY |
| LABELING; Labeling | SUPPL | 16 | AP | 2012-03-30 | STANDARD |
| LABELING; Labeling | SUPPL | 47 | AP | 2013-12-13 | STANDARD |
| LABELING; Labeling | SUPPL | 53 | AP | 2014-04-03 | STANDARD |
| LABELING; Labeling | SUPPL | 55 | AP | 2016-12-02 | STANDARD |
| LABELING; Labeling | SUPPL | 57 | AP | 2017-01-18 | STANDARD |
| LABELING; Labeling | SUPPL | 62 | AP | 2018-06-22 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 64 | AP | 2019-04-26 | PRIORITY |
| LABELING; Labeling | SUPPL | 67 | AP | 2019-09-13 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 68 | AP | 2020-01-17 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 71 | AP | 2020-09-24 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 73 | AP | 2020-12-16 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 78 | AP | 2022-07-26 | PRIORITY |
Submissions Property Types
| ORIG | 1 | Null | 2 |
| SUPPL | 55 | Null | 7 |
| SUPPL | 57 | Null | 7 |
| SUPPL | 62 | Null | 6 |
| SUPPL | 64 | Null | 15 |
| SUPPL | 67 | Null | 7 |
| SUPPL | 68 | Null | 15 |
| SUPPL | 71 | Null | 7 |
| SUPPL | 73 | Null | 7 |
| SUPPL | 78 | Null | 6 |
CDER Filings
HUMAN GENOME SCIENCES INC.
cder:Array
(
[0] => Array
(
[ApplNo] => 125370
[companyName] => HUMAN GENOME SCIENCES INC.
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[actionDate] => 2020-12-16
)
)