ANDA 211594

ALVOGEN MALTA

FDA Drug Application

Application #211594

Documents

• Letter: 2021-03-10

Application Sponsors

ANDA 211594

ALVOGEN MALTA

Marketing Status

• None (Tentative Approval): 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006
• Prescription: 007

Application Products

001	FILM;BUCCAL	EQ 0.075MG BASE	0	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE
002	FILM;BUCCAL	EQ 0.15MG BASE	0	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE
003	FILM;BUCCAL	EQ 0.3MG BASE	0	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE
004	FILM;BUCCAL	EQ 0.45MG BASE	0	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE
005	FILM;BUCCAL	EQ 0.6MG BASE	0	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE
006	FILM;BUCCAL	EQ 0.75MG BASE	0	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE
007	FILM;BUCCAL	EQ 0.9MG BASE	0	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-06-12

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB
006	Prescription	AB
007	Prescription	AB

CDER Filings

ALVOGEN MALTA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211594
            [companyName] => ALVOGEN MALTA
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUPRENORPHINE HYDROCHLORIDE","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/12\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-06-12
        )

)