ANDA 072123

AM REGENT

FDA Drug Application

Application #072123

Application Sponsors

ANDA 072123

AM REGENT

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

2.5MG/ML

0

DROPERIDOL

DROPERIDOL

FDA Submissions

	ORIG	1	AP	1988-10-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1995-05-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1994-10-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1996-02-28
LABELING; Labeling	SUPPL	5	AP	1995-02-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1998-07-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1999-03-25
LABELING; Labeling	SUPPL	12	AP	2002-01-10

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0

TE Codes

001

Prescription

AP

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 72123
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"DROPERIDOL","activeIngredients":"DROPERIDOL","strength":"2.5MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DROPERIDOL","submission":"DROPERIDOL","actionType":"2.5MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)