Documents
Application Sponsors
| BLA 761097 | REGENERON PHARMACEUTICALS | |
Marketing Status
Application Products
| 001 | INJECTABLE;INTRAVENOUS | 350MG | 0 | LIBTAYO | CEMIPLIMAB-RWLC |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2018-09-28 | PRIORITY |
| LABELING; Labeling | SUPPL | 2 | AP | 2019-01-18 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2020-11-10 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2020-06-25 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2021-02-22 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2021-02-09 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 9 | AP | 2021-02-09 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 14 | AP | 2022-11-08 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 6 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 6 |
| SUPPL | 9 | Null | 7 |
| SUPPL | 14 | Null | 15 |
CDER Filings
REGENERON PHARMACEUTICALS
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[companyName] => REGENERON PHARMACEUTICALS
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[actionDate] => 2020-06-25
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