Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE; INJECTION | 25MG/0.5ML | 0 | ERELZI | ETANERCEPT-SZZS |
| 002 | INJECTABLE; INJECTION | 50MG/ML | 0 | ERELZI | ETANERCEPT-SZZS |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2016-08-30 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 10 | AP | 2019-10-18 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 12 | AP | 2020-06-11 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 18 | AP | 2022-11-10 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 18 | Null | 46 |
CDER Filings
SANDOZ
cder:Array
(
[0] => Array
(
[ApplNo] => 761042
[companyName] => SANDOZ
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/761042s012lbl.pdf#page=39"]
[products] => [{"drugName":"ERELZI","activeIngredients":"ETANERCEPT-SZZS","strength":"25MG\/0.5ML","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ERELZI","activeIngredients":"ETANERCEPT-SZZS","strength":"50MG\/ML","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"06\/11\/2020","submission":"SUPPL-12","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761042s012lbl.pdf\"}]","notes":""},{"actionDate":"10\/18\/2019","submission":"SUPPL-10","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761042s010lbl.pdf\"}]","notes":""},{"actionDate":"01\/26\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761042s001lbl.pdf\"}]","notes":""},{"actionDate":"01\/26\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761042s001lbl.pdf\"}]","notes":""},{"actionDate":"08\/30\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/761042lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"08\/30\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/761042lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/761042Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/761042Orig1_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/761042Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"06\/11\/2020","submission":"SUPPL-12","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761042s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761042Orig1s012ltr.pdf\"}]","notes":">"},{"actionDate":"10\/18\/2019","submission":"SUPPL-10","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761042s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761042Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"01\/26\/2018","submission":"SUPPL-1","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761042s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761042Orig1s001ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/761042Orig1s01.pdf\"}]","notes":">"}]
[actionDate] => 2020-06-11
)
)