AVEVA FDA Approval ANDA 210272

ANDA 210272

AVEVA

FDA Drug Application

Application #210272

Application Sponsors

ANDA 210272AVEVA

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005

Application Products

001FILM, EXTENDED RELEASE;TRANSDERMAL5MCG/HR0BUPRENORPHINEBUPRENORPHINE
002FILM, EXTENDED RELEASE;TRANSDERMAL7.5MCG/HR0BUPRENORPHINEBUPRENORPHINE
003FILM, EXTENDED RELEASE;TRANSDERMAL10MCG/HR0BUPRENORPHINEBUPRENORPHINE
004FILM, EXTENDED RELEASE;TRANSDERMAL15MCG/HR0BUPRENORPHINEBUPRENORPHINE
005FILM, EXTENDED RELEASE;TRANSDERMAL20MCG/HR0BUPRENORPHINEBUPRENORPHINE

FDA Submissions

UNKNOWN; ORIG1AP2021-09-23STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB

CDER Filings

AVEVA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210272
            [companyName] => AVEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUPRENORPHINE","activeIngredients":"BUPRENORPHINE","strength":"5MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUPRENORPHINE","activeIngredients":"BUPRENORPHINE","strength":"7.5MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUPRENORPHINE","activeIngredients":"BUPRENORPHINE","strength":"10MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUPRENORPHINE","activeIngredients":"BUPRENORPHINE","strength":"15MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUPRENORPHINE","activeIngredients":"BUPRENORPHINE","strength":"20MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/23\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-09-23
        )

)

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