ANDA 074961

CONTRACT PHARMACAL

FDA Drug Application

Application #074961

Documents

• Letter: 2004-06-01

Application Sponsors

ANDA 074961

CONTRACT PHARMACAL

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

200MG

0

CIMETIDINE

CIMETIDINE

FDA Submissions

	ORIG	1	AP	1998-06-19
LABELING; Labeling	SUPPL	2	AP	1999-01-26
LABELING; Labeling	SUPPL	3	AP	2000-01-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2000-08-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-09-21

Submissions Property Types

SUPPL	1	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0

CDER Filings

CONTRACT PHARMACAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74961
            [companyName] => CONTRACT PHARMACAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"CIMETIDINE","activeIngredients":"CIMETIDINE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CIMETIDINE","submission":"CIMETIDINE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)