ANDA 083215

UPSHER SMITH LABS

FDA Drug Application

Application #083215

Application Sponsors

ANDA 083215

UPSHER SMITH LABS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

4MG

0

BROMPHENIRAMINE MALEATE

BROMPHENIRAMINE MALEATE

FDA Submissions

	ORIG	1	AP	1975-12-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1982-04-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1982-07-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1982-07-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1982-07-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1982-09-30

Submissions Property Types

SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83215
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"BROMPHENIRAMINE MALEATE","activeIngredients":"BROMPHENIRAMINE MALEATE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BROMPHENIRAMINE MALEATE","submission":"BROMPHENIRAMINE MALEATE","actionType":"4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)