ANDA 212756

AVEVA

FDA Drug Application

Application #212756

Application Sponsors

ANDA 212756

AVEVA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	FILM;BUCCAL, SUBLINGUAL	EQ 8MG BASE;EQ 2MG BASE	0	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
002	FILM;BUCCAL, SUBLINGUAL	EQ 12MG BASE;EQ 3MG BASE	0	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2022-06-02	STANDARD
REMS; REMS	SUPPL	2	AP	2022-12-16

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

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
        )

)