NDA 211635

NEURELIS INC

FDA Drug Application

Application #211635

Documents

• Label: 2020-01-13
• Medication Guide: 2020-01-13
• Letter: 2020-01-14
• Review: 2020-09-10
• Letter: 2021-02-09
• Label: 2021-02-09
• Medication Guide: 2021-02-09
• Letter: 2022-02-08
• Label: 2022-02-08
• Medication Guide: 2022-02-08
• Letter: 2023-01-17
• Label: 2023-01-17
• Medication Guide: 2023-01-17

Application Sponsors

NDA 211635

NEURELIS INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	SPRAY;NASAL	5MG/SPRAY	1	VALTOCO	DIAZEPAM
002	SPRAY;NASAL	7.5MG/SPRAY	1	VALTOCO	DIAZEPAM
003	SPRAY;NASAL	10MG/SPRAY	1	VALTOCO	DIAZEPAM

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2020-01-10	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-02-05	STANDARD
LABELING; Labeling	SUPPL	7	AP	2022-02-04	STANDARD
LABELING; Labeling	SUPPL	8	AP	2023-01-13	STANDARD

Submissions Property Types

ORIG	1	Null	2
SUPPL	3	Null	15
SUPPL	7	Null	7
SUPPL	8	Null	6

CDER Filings

NEURELIS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211635
            [companyName] => NEURELIS INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/211635s003lbl.pdf#page=25"]
            [products] => [{"drugName":"VALTOCO","activeIngredients":"DIAZEPAM","strength":"5MG\/SPRAY","dosageForm":"SPRAY;NASAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"VALTOCO","activeIngredients":"DIAZEPAM","strength":"7.5MG\/SPRAY","dosageForm":"SPRAY;NASAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"VALTOCO","activeIngredients":"DIAZEPAM","strength":"10MG\/SPRAY","dosageForm":"SPRAY;NASAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/05\/2021","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/211635s003lbl.pdf\"}]","notes":""},{"actionDate":"02\/05\/2021","submission":"SUPPL-3","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/211635s003lbl.pdf\"}]","notes":""},{"actionDate":"01\/10\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211635s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/10\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211635s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211635Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/211635Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"02\/05\/2021","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/211635s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/211635Orig1s003ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2021-02-05
        )

)