ANDA 072125

PLIVA

FDA Drug Application

Application #072125

Application Sponsors

ANDA 072125

PLIVA

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

120MG

0

VERAPAMIL HYDROCHLORIDE

VERAPAMIL HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1989-01-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1992-02-10
LABELING; Labeling	SUPPL	3	AP	1992-04-06
LABELING; Labeling	SUPPL	4	AP	1992-09-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1994-05-11
LABELING; Labeling	SUPPL	7	AP	1998-08-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-07-07

Submissions Property Types

SUPPL	2	Null	0
SUPPL	5	Null	0
SUPPL	8	Null	0

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 72125
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"VERAPAMIL HYDROCHLORIDE","activeIngredients":"VERAPAMIL HYDROCHLORIDE","strength":"120MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VERAPAMIL HYDROCHLORIDE","submission":"VERAPAMIL HYDROCHLORIDE","actionType":"120MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)