Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 20MG/0.4ML | 0 | AMJEVITA | ADALIMUMAB-ATTO |
| 002 | INJECTABLE;INJECTION | 40MG/0.8ML | 0 | AMJEVITA | ADALIMUMAB-ATTO |
FDA Submissions
| TYPE 2/4; Type 2 New Active Ingredient and Type 4 New Combination | ORIG | 1 | AP | 2016-09-23 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2018-03-15 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2019-06-13 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 10 | AP | 2022-07-28 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 10 | Null | 46 |
CDER Filings
AMGEN INC
cder:Array
(
[0] => Array
(
[ApplNo] => 761024
[companyName] => AMGEN INC
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/761024s004lbl.pdf#page=39"]
[products] => [{"drugName":"AMJEVITA","activeIngredients":"ADALIMUMAB-ATTO","strength":"20MG\/0.4ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"AMJEVITA","activeIngredients":"ADALIMUMAB-ATTO","strength":"40MG\/0.8ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"06\/13\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761024s004lbl.pdf\"}]","notes":""},{"actionDate":"06\/13\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761024s004lbl.pdf\"}]","notes":""},{"actionDate":"03\/15\/2018","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761024s003lbl.pdf\"}]","notes":""},{"actionDate":"09\/23\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/761024lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"09\/23\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/761024lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/761024Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/761024_toc.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"06\/13\/2019","submission":"SUPPL-4","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761024s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761024Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"03\/15\/2018","submission":"SUPPL-3","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761024s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761024Orig1s003ltr.pdf\"}]","notes":">"}]
[actionDate] => 2019-06-13
)
)