ANDA 071793

GUARDIAN DRUG

FDA Drug Application

Application #071793

Application Sponsors

ANDA 071793

GUARDIAN DRUG

Marketing Status

• Discontinued: 001

Application Products

001

TABLET, CHEWABLE;ORAL

80MG;20MG

0

FOAMCOAT

ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE

FDA Submissions

	ORIG	1	AP	1987-09-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1992-11-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1992-11-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2001-06-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2001-06-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-06-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2001-06-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2001-06-05

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0

CDER Filings

GUARDIAN DRUG

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 71793
            [companyName] => GUARDIAN DRUG
            [docInserts] => ["",""]
            [products] => [{"drugName":"FOAMCOAT","activeIngredients":"ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE","strength":"80MG;20MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FOAMCOAT","submission":"ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE","actionType":"80MG;20MG","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)