Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | SYRINGE | 22UG/0.5ML | 0 | REBIF | INTERFERON BETA-1A |
| 002 | SYRINGE | 44UG/0.5ML | 0 | REBIF | INTERFERON BETA-1A |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2002-03-07 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 5010 | AP | 2003-05-02 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5027 | AP | 2004-03-26 | STANDARD |
| LABELING; Labeling | SUPPL | 5030 | AP | 2004-12-23 | STANDARD |
| S; Supplement | SUPPL | 5052 | AP | 2004-12-17 | |
| LABELING; Labeling | SUPPL | 5062 | AP | 2005-06-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5121 | AP | 2012-12-21 | |
| LABELING; Labeling | SUPPL | 5140 | AP | 2013-04-19 | STANDARD |
| LABELING; Labeling | SUPPL | 5172 | AP | 2015-03-10 | STANDARD |
| LABELING; Labeling | SUPPL | 5178 | AP | 2014-04-24 | STANDARD |
| LABELING; Labeling | SUPPL | 5179 | AP | 2014-04-24 | STANDARD |
| LABELING; Labeling | SUPPL | 5194 | AP | 2015-12-22 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5196 | AP | 2016-09-27 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5203 | AP | 2020-05-26 | STANDARD |
| LABELING; Labeling | SUPPL | 5204 | AP | 2019-07-09 | STANDARD |
| LABELING; Labeling | SUPPL | 5207 | AP | 2020-05-26 | STANDARD |
| LABELING; Labeling | SUPPL | 5210 | AP | 2021-11-03 | STANDARD |
Submissions Property Types
| SUPPL | 5052 | Null | 0 |
| SUPPL | 5121 | Null | 0 |
| SUPPL | 5172 | Null | 6 |
| SUPPL | 5194 | Null | 15 |
| SUPPL | 5196 | Null | 15 |
| SUPPL | 5203 | Null | 15 |
| SUPPL | 5204 | Null | 15 |
| SUPPL | 5207 | Null | 15 |
| SUPPL | 5210 | Null | 6 |
CDER Filings
SERONO INC
cder:Array
(
[0] => Array
(
[ApplNo] => 103780
[companyName] => SERONO INC
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/103780s5203s5207lbl.pdf#page=16"]
[products] => [{"drugName":"REBIF","activeIngredients":"INTERFERON BETA-1A","strength":"22UG\/0.5ML","dosageForm":"SYRINGE","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"REBIF","activeIngredients":"INTERFERON BETA-1A","strength":"44UG\/0.5ML","dosageForm":"SYRINGE","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"05\/26\/2020","submission":"SUPPL-5207","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/103780s5203s5207lbl.pdf\"}]","notes":""},{"actionDate":"05\/26\/2020","submission":"SUPPL-5203","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/103780s5203s5207lbl.pdf\"}]","notes":""},{"actionDate":"07\/09\/2019","submission":"SUPPL-5204","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/103780s5204lbl.pdf\"}]","notes":""},{"actionDate":"07\/09\/2019","submission":"SUPPL-5204","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/103780s5204lbl.pdf\"}]","notes":""},{"actionDate":"09\/27\/2016","submission":"SUPPL-5196","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/103780s5196lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2015","submission":"SUPPL-5194","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/103780s5194lbl.pdf\"}]","notes":""},{"actionDate":"03\/10\/2015","submission":"SUPPL-5172","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/103780s5172lbl.pdf\"}]","notes":""},{"actionDate":"04\/24\/2014","submission":"SUPPL-5179","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/103780s5178s5179lbl.pdf\"}]","notes":""},{"actionDate":"04\/24\/2014","submission":"SUPPL-5178","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/103780s5178s5179lbl.pdf\"}]","notes":""},{"actionDate":"04\/19\/2013","submission":"SUPPL-5140","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/103780s5140lbl.pdf\"}]","notes":""},{"actionDate":"12\/21\/2012","submission":"SUPPL-5121","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/103780s5121lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"06\/30\/2005","submission":"SUPPL-5062","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/103780s5062lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/2004","submission":"SUPPL-5030","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/103780_5030lbl.pdf\"}]","notes":""},{"actionDate":"12\/17\/2004","submission":"SUPPL-5052","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/103780_5052lbl.pdf\"}]","notes":""},{"actionDate":"05\/02\/2003","submission":"SUPPL-5010","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/ifnbser050203LB.pdf\"}]","notes":""},{"actionDate":"03\/07\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/ifnbser030702LB.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"03\/07\/2002","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/ifnbser030702LB.pdf\"},{\"name\":\"Letter\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2002\\\/ifnbser030702L.htm\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/web.archive.org\\\/web\\\/20170118085129\\\/https:\\\/\\\/www.fda.gov\\\/Drugs\\\/DevelopmentApprovalProcess\\\/HowDrugsareDevelopedandApproved\\\/ApprovalApplications\\\/TherapeuticBiologicApplications\\\/ucm080737.htm\"}]","notes":">"}]
[supplements] => [{"actionDate":"05\/26\/2020","submission":"SUPPL-5207","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/103780s5203s5207lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/103780Orig1s5203s5207ltr.pdf\"}]","notes":">"},{"actionDate":"07\/09\/2019","submission":"SUPPL-5204","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/103780s5204lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/103780Orig1s5204ltr.pdf\"}]","notes":">"},{"actionDate":"05\/26\/2020","submission":"SUPPL-5203","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/103780s5203s5207lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/103780Orig1s5203s5207ltr.pdf\"}]","notes":">"},{"actionDate":"09\/27\/2016","submission":"SUPPL-5196","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/103780s5196lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/103780Orig1s5196ltr.pdf\"}]","notes":">"},{"actionDate":"12\/22\/2015","submission":"SUPPL-5194","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/103780s5194lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/103780Orig1s5194ltr.pdf\"}]","notes":">"},{"actionDate":"04\/24\/2014","submission":"SUPPL-5179","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/103780s5178s5179lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/103780Orig1s5178,s5179ltr.pdf\"}]","notes":">"},{"actionDate":"04\/24\/2014","submission":"SUPPL-5178","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/103780s5178s5179lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/103780Orig1s5178,s5179ltr.pdf\"}]","notes":">"},{"actionDate":"03\/10\/2015","submission":"SUPPL-5172","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/103780s5172lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/103780Orig1s5172ltr.pdf\"}]","notes":">"},{"actionDate":"04\/19\/2013","submission":"SUPPL-5140","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/103780s5140lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/103780Orig1s5140ltr.pdf\"}]","notes":">"},{"actionDate":"12\/21\/2012","submission":"SUPPL-5121","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/103780s5121lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/103780Orig1s5121ltr.pdf\"}]","notes":">"},{"actionDate":"06\/30\/2005","submission":"SUPPL-5062","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/103780s5062lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2005\\\/103780s5062ltr.pdf\"}]","notes":">"},{"actionDate":"12\/17\/2004","submission":"SUPPL-5052","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/103780_5052lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2004\\\/103780_5052ltr.pdf\"}]","notes":">"},{"actionDate":"12\/23\/2004","submission":"SUPPL-5030","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/103780_5030lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2004\\\/103780_5030ltr.pdf\"}]","notes":">"},{"actionDate":"03\/26\/2004","submission":"SUPPL-5027","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/02\/2003","submission":"SUPPL-5010","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/ifnbser050203LB.pdf\"},{\"name\":\"Letter\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2003\\\/ifnbser050203L.htm\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/web.archive.org\\\/web\\\/20120303004314\\\/https:\\\/\\\/www.fda.gov\\\/Drugs\\\/DevelopmentApprovalProcess\\\/HowDrugsareDevelopedandApproved\\\/ApprovalApplications\\\/TherapeuticBiologicApplications\\\/ucm080739.htm\"}]","notes":">"}]
[actionDate] => 2020-05-26
)
)