ANDA 074874

PLIVA

FDA Drug Application

Application #074874

Documents

• Letter: 1999-05-25

Application Sponsors

ANDA 074874

PLIVA

Marketing Status

• Discontinued: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

400MG

0

PENTOXIFYLLINE

PENTOXIFYLLINE

FDA Submissions

	ORIG	1	AP	1999-05-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-07-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-11-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2002-11-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2002-11-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2002-11-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2002-11-18
LABELING; Labeling	SUPPL	8	AP	2002-11-18

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74874
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PENTOXIFYLLINE","activeIngredients":"PENTOXIFYLLINE","strength":"400MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PENTOXIFYLLINE","submission":"PENTOXIFYLLINE","actionType":"400MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)