ANDA 078331

AM REGENT

FDA Drug Application

Application #078331

Application Sponsors

ANDA 078331

AM REGENT

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 0.3MG BASE/ML

0

BUPRENORPHINE HYDROCHLORIDE

BUPRENORPHINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2007-03-27
LABELING; Labeling	SUPPL	7	AP	2020-06-23	STANDARD
LABELING; Labeling	SUPPL	9	AP	2020-06-23	STANDARD

Submissions Property Types

SUPPL	7	Null	7
SUPPL	9	Null	7

TE Codes

001

Prescription

AP

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78331
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUPRENORPHINE HYDROCHLORIDE","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE","strength":"EQ 0.3MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BUPRENORPHINE HYDROCHLORIDE","submission":"BUPRENORPHINE HYDROCHLORIDE","actionType":"EQ 0.3MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)