ANDA 075128

WATSON LABS TEVA

FDA Drug Application

Application #075128

Documents

• Letter: 2000-03-10
• Review: 2005-07-22
• Letter: 2004-06-10

Application Sponsors

ANDA 075128

WATSON LABS TEVA

Marketing Status

• Discontinued: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

30MG

0

AFEDITAB CR

NIFEDIPINE

FDA Submissions

	ORIG	1	AP	2000-03-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-01-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-07-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2002-07-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2002-12-30
LABELING; Labeling	SUPPL	11	AP	2005-05-03

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0

CDER Filings

WATSON LABS TEVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75128
            [companyName] => WATSON LABS TEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"AFEDITAB CR","activeIngredients":"NIFEDIPINE","strength":"30MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AFEDITAB CR","submission":"NIFEDIPINE","actionType":"30MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)