ANDA 072547

AM REGENT

FDA Drug Application

Application #072547

Application Sponsors

ANDA 072547

AM REGENT

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INHALATION, ORAL

20%

0

ACETYLCYSTEINE

ACETYLCYSTEINE

FDA Submissions

	ORIG	1	AP	1995-07-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1999-11-04
LABELING; Labeling	SUPPL	3	AP	1998-09-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1999-07-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2001-04-12

Submissions Property Types

SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0

TE Codes

001

Prescription

AN

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 72547
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETYLCYSTEINE","activeIngredients":"ACETYLCYSTEINE","strength":"20%","dosageForm":"SOLUTION;INHALATION, ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACETYLCYSTEINE","submission":"ACETYLCYSTEINE","actionType":"20%","submissionClassification":"SOLUTION;INHALATION, ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)