ANDA 075738

MALLINCKRODT

FDA Drug Application

Application #075738

Documents

• Letter: 2001-02-02

Application Sponsors

ANDA 075738

MALLINCKRODT

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

650MG;100MG

0

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

FDA Submissions

	ORIG	1	AP	2001-02-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-12-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-12-03
LABELING; Labeling	SUPPL	4	AP	2002-12-03

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0

CDER Filings

MALLINCKRODT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75738
            [companyName] => MALLINCKRODT
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE","strength":"650MG;100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE","actionType":"650MG;100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)