ANDA 088682

ANI PHARMS INC

FDA Drug Application

Application #088682

Application Sponsors

ANDA 088682

ANI PHARMS INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

2MG

0

DEXCHLORPHENIRAMINE MALEATE

DEXCHLORPHENIRAMINE MALEATE

FDA Submissions

	ORIG	1	AP	1986-01-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1994-05-11

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0

CDER Filings

ANI PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88682
            [companyName] => ANI PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXCHLORPHENIRAMINE MALEATE","activeIngredients":"DEXCHLORPHENIRAMINE MALEATE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DEXCHLORPHENIRAMINE MALEATE","submission":"DEXCHLORPHENIRAMINE MALEATE","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)