NDA 211321

UCB INC

FDA Drug Application

Application #211321

Documents

• Label: 2019-05-17
• Medication Guide: 2019-05-17
• Letter: 2019-06-20
• Review: 2020-03-10
• Letter: 2021-02-09
• Label: 2021-02-09
• Medication Guide: 2021-02-09
• Letter: 2023-01-17
• Label: 2023-01-17
• Medication Guide: 2023-01-17

Application Sponsors

NDA 211321

UCB INC

Marketing Status

• Prescription: 001

Application Products

001

SPRAY;NASAL

5MG/SPRAY

1

NAYZILAM

MIDAZOLAM

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2019-05-17	STANDARD
LABELING; Labeling	SUPPL	5	AP	2021-02-05	STANDARD
LABELING; Labeling	SUPPL	8	AP	2023-01-13	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	15
SUPPL	8	Null	6

CDER Filings

UCB INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211321
            [companyName] => UCB INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/211321s000lbl.pdf#page=24"]
            [products] => [{"drugName":"NAYZILAM","activeIngredients":"MIDAZOLAM","strength":"5MG\/SPRAY","dosageForm":"SPRAY;NASAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/17\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211321s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/17\/2019","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\\\/2019\\\/211321s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211321Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/211321Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-05-17
        )

)