AVEVA FDA Approval ANDA 212756

ANDA 212756

AVEVA

FDA Drug Application

Application #212756

Application Sponsors

ANDA 212756AVEVA

Marketing Status

Prescription001
Prescription002

Application Products

001FILM;BUCCAL, SUBLINGUALEQ 8MG BASE;EQ 2MG BASE0BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
002FILM;BUCCAL, SUBLINGUALEQ 12MG BASE;EQ 3MG BASE0BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-06-02STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

AVEVA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212756
            [companyName] => AVEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","strength":"EQ 8MG BASE;EQ 2MG BASE","dosageForm":"FILM;BUCCAL, SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","strength":"EQ 12MG BASE;EQ 3MG BASE","dosageForm":"FILM;BUCCAL, SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/02\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-02
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.