ANDA 072034

AM REGENT

FDA Drug Application

Application #072034

Application Sponsors

ANDA 072034

AM REGENT

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

5MG/ML

0

NITROGLYCERIN

NITROGLYCERIN

FDA Submissions

	ORIG	1	AP	1988-05-24
LABELING; Labeling	SUPPL	2	AP	1991-01-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1992-05-07
LABELING; Labeling	SUPPL	4	AP	1992-11-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1994-08-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1996-02-28
LABELING; Labeling	SUPPL	7	AP	1996-06-13
LABELING; Labeling	SUPPL	10	AP	1996-08-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1997-11-05
LABELING; Labeling	SUPPL	12	AP	1999-07-21

Submissions Property Types

SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	11	Null	0

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 72034
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"NITROGLYCERIN","activeIngredients":"NITROGLYCERIN","strength":"5MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NITROGLYCERIN","submission":"NITROGLYCERIN","actionType":"5MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)