Documents
Application Sponsors
Marketing Status
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
)
)