ANDA 070797

AUROLIFE PHARMA LLC

FDA Drug Application

Application #070797

Application Sponsors

ANDA 070797

AUROLIFE PHARMA LLC

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE, EXTENDED RELEASE;ORAL

12MG

0

CHLORPHENIRAMINE MALEATE

CHLORPHENIRAMINE MALEATE

FDA Submissions

	ORIG	1	AP	1988-08-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1994-07-29

Submissions Property Types

SUPPL

5

Null

0

CDER Filings

AUROLIFE PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70797
            [companyName] => AUROLIFE PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORPHENIRAMINE MALEATE","activeIngredients":"CHLORPHENIRAMINE MALEATE","strength":"12MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CHLORPHENIRAMINE MALEATE","submission":"CHLORPHENIRAMINE MALEATE","actionType":"12MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)