AQUESTIVE FDA Approval NDA 212641

NDA 212641

AQUESTIVE

FDA Drug Application

Application #212641

Documents

Letter2022-08-31

Application Sponsors

NDA 212641AQUESTIVE

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006
Prescription007

Application Products

001FILM;BUCCAL5MG0DIAZEPAMDIAZEPAM
002FILM;BUCCAL7.5MG0DIAZEPAMDIAZEPAM
003FILM;BUCCAL10MG0DIAZEPAMDIAZEPAM
004FILM;BUCCAL12.5MG0DIAZEPAMDIAZEPAM
005FILM;BUCCAL15MG0DIAZEPAMDIAZEPAM
006FILM;BUCCAL17.5MG0DIAZEPAMDIAZEPAM
007FILM;BUCCAL20MG0DIAZEPAMDIAZEPAM

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1TA2022-08-30STANDARD

Submissions Property Types

ORIG1Null10

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
        )

)

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