Documents
Application Sponsors
Marketing Status
Application Products
001 | SPRAY;NASAL | EQ 28MG BASE | 1 | SPRAVATO | ESKETAMINE HYDROCHLORIDE |
FDA Submissions
TYPE 2; Type 2 - New Active Ingredient | ORIG | 1 | AP | 2019-03-05 | PRIORITY |
REMS; REMS | SUPPL | 2 | AP | 2019-06-25 | N/A |
LABELING; Labeling | SUPPL | 3 | AP | 2020-02-11 | STANDARD |
EFFICACY; Efficacy | SUPPL | 4 | AP | 2020-07-31 | STANDARD |
REMS; REMS | SUPPL | 6 | AP | 2022-01-03 | N/A |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 2 | Null | 15 |
SUPPL | 3 | Null | 6 |
SUPPL | 4 | Null | 6 |
SUPPL | 6 | Null | 7 |
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 211243
[companyName] => JANSSEN PHARMS
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/211243s004lbl.pdf#page=42"]
[products] => [{"drugName":"SPRAVATO","activeIngredients":"ESKETAMINE HYDROCHLORIDE","strength":"EQ 28MG BASE","dosageForm":"SPRAY;NASAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"07\/31\/2020","submission":"SUPPL-4","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211243s004lbl.pdf\"}]","notes":""},{"actionDate":"02\/11\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211243s003lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211243s001lbl.pdf\"}]","notes":""},{"actionDate":"03\/05\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211243lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"03\/05\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 2 - New Active Ingredient","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211243lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211243Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/211243Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"01\/03\/2022","submission":"SUPPL-6","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/211243Orig1s006ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"07\/31\/2020","submission":"SUPPL-4","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211243s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211243Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"02\/11\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211243s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211243Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"06\/25\/2019","submission":"SUPPL-2","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211243Orig1s002ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"05\/09\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211243s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211243Orig1s001ltr.pdf\"}]","notes":">"}]
[actionDate] => 2022-01-03
)
)