Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | EQ 0.25MG BASE | 1 | MAYZENT | SIPONIMOD FUMARIC ACID |
| 002 | TABLET;ORAL | EQ 2MG BASE | 1 | MAYZENT | SIPONIMOD FUMARIC ACID |
| 003 | TABLET;ORAL | EQ 1MG BASE | 1 | MAYZENT | SIPONIMOD FUMARIC ACID |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2019-03-26 | PRIORITY |
| LABELING; Labeling | SUPPL | 2 | TA | 2020-07-30 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2021-01-23 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2021-09-10 | STANDARD |
| S; Supplement | SUPPL | 6 | AP | 2021-08-24 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2022-03-01 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2022-06-10 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2022-06-21 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 7 | Null | 6 |
| SUPPL | 10 | Null | 15 |
| SUPPL | 11 | Null | 15 |
CDER Filings
NOVARTIS
cder:Array
(
[0] => Array
(
[ApplNo] => 209884
[companyName] => NOVARTIS
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/209884Orig1s011lbl.pdf#page=23"]
[products] => [{"drugName":"MAYZENT","activeIngredients":"SIPONIMOD FUMARIC ACID","strength":"EQ 0.25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"MAYZENT","activeIngredients":"SIPONIMOD FUMARIC ACID","strength":"EQ 2MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"MAYZENT","activeIngredients":"SIPONIMOD FUMARIC ACID","strength":"EQ 1MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"06\/21\/2022","submission":"SUPPL-11","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/209884Orig1s011lbl.pdf\"}]","notes":""},{"actionDate":"06\/10\/2022","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/209884s010lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2022","submission":"SUPPL-7","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/209884s007lbl.pdf\"}]","notes":""},{"actionDate":"08\/24\/2021","submission":"SUPPL-6","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/209884Orig1s006Lbledt.pdf\"}]","notes":""},{"actionDate":"01\/23\/2021","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/209884s003lbl.pdf\"}]","notes":""},{"actionDate":"07\/31\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209884s002lbl.pdf\"}]","notes":""},{"actionDate":"07\/31\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209884s002lbl.pdf\"}]","notes":""},{"actionDate":"03\/26\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209884s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"03\/26\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209884s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209884Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/209884Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"06\/21\/2022","submission":"SUPPL-11","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/209884Orig1s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/209884Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"06\/10\/2022","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/209884s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/209884Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"03\/01\/2022","submission":"SUPPL-7","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/209884s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/209884Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"08\/24\/2021","submission":"SUPPL-6","supplementCategories":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/209884Orig1s006Lbledt.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/209884Orig1s006CorrectedLtr.pdf\"}]","notes":">"},{"actionDate":"09\/10\/2021","submission":"SUPPL-5","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/209884Orig1s005ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"01\/23\/2021","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/209884s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/209884Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"07\/31\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209884s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209884Orig1s002ltr.pdf\"}]","notes":">"}]
[actionDate] => 2022-06-21
)
)