NDA 211243

JANSSEN PHARMS

FDA Drug Application

Application #211243

Documents

• Label: 2019-03-06
• Medication Guide: 2019-03-06
• Letter: 2019-03-06
• REMS: 2019-04-05
• Label: 2019-05-10
• Medication Guide: 2019-05-10
• Letter: 2019-05-13
• Letter: 2019-06-26
• Review: 2019-07-02
• Letter: 2020-02-12
• Label: 2020-02-12
• Medication Guide: 2020-02-12
• Letter: 2020-08-03
• Label: 2020-08-03
• Medication Guide: 2020-08-03
• Letter: 2022-01-05
• Review: 2022-12-09
• Review: 2023-01-25

Application Sponsors

NDA 211243

JANSSEN PHARMS

Marketing Status

• Prescription: 001

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
        )

)