Documents
Application Sponsors
| BLA 761113 | SANOFI AVENTIS US | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 100MG/5ML (20MG/ML) | 0 | SARCLISA | ISATUXIMAB-IRFC |
| 002 | INJECTABLE;INJECTION | 500MG/25ML (20MG/ML) | 0 | SARCLISA | ISATUXIMAB-IRFC |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2020-03-02 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2021-03-31 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2021-03-18 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2022-07-15 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 3 | Null | 6 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 6 | Null | 6 |
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 761113
[companyName] => SANOFI AVENTIS US
[docInserts] => ["",""]
[products] => [{"drugName":"SARCLISA","activeIngredients":"ISATUXIMAB-IRFC","strength":"100MG\/5ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SARCLISA","activeIngredients":"ISATUXIMAB-IRFC","strength":"500MG\/25ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"03\/02\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761113s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"03\/02\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761113s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761113Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/761113Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2020-03-02
)
)