NDA 212641

AQUESTIVE

FDA Drug Application

Application #212641

Documents

• Letter: 2022-08-31

Application Sponsors

NDA 212641

AQUESTIVE

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006
• Prescription: 007

Application Products

001	FILM;BUCCAL	5MG	0	DIAZEPAM	DIAZEPAM
002	FILM;BUCCAL	7.5MG	0	DIAZEPAM	DIAZEPAM
003	FILM;BUCCAL	10MG	0	DIAZEPAM	DIAZEPAM
004	FILM;BUCCAL	12.5MG	0	DIAZEPAM	DIAZEPAM
005	FILM;BUCCAL	15MG	0	DIAZEPAM	DIAZEPAM
006	FILM;BUCCAL	17.5MG	0	DIAZEPAM	DIAZEPAM
007	FILM;BUCCAL	20MG	0	DIAZEPAM	DIAZEPAM

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

TA

2022-08-30

STANDARD

Submissions Property Types

ORIG

1

Null

10

CDER Filings

AQUESTIVE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212641
            [companyName] => AQUESTIVE
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIAZEPAM","activeIngredients":"DIAZEPAM","strength":"5MG","dosageForm":"FILM;BUCCAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DIAZEPAM","activeIngredients":"DIAZEPAM","strength":"7.5MG","dosageForm":"FILM;BUCCAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DIAZEPAM","activeIngredients":"DIAZEPAM","strength":"10MG","dosageForm":"FILM;BUCCAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DIAZEPAM","activeIngredients":"DIAZEPAM","strength":"12.5MG","dosageForm":"FILM;BUCCAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DIAZEPAM","activeIngredients":"DIAZEPAM","strength":"15MG","dosageForm":"FILM;BUCCAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DIAZEPAM","activeIngredients":"DIAZEPAM","strength":"17.5MG","dosageForm":"FILM;BUCCAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DIAZEPAM","activeIngredients":"DIAZEPAM","strength":"20MG","dosageForm":"FILM;BUCCAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/30\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/212641Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-30
        )

)