ANDA 076911

SUN PHARM INDS LTD

FDA Drug Application

Application #076911

Application Sponsors

ANDA 076911

SUN PHARM INDS LTD

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET;ORAL	3.75MG	0	CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM
002	TABLET;ORAL	7.5MG	0	CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM
003	TABLET;ORAL	15MG	0	CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM

FDA Submissions

	ORIG	1	AP	2004-09-29
LABELING; Labeling	SUPPL	4	AP	2009-08-05
LABELING; Labeling	SUPPL	5	AP	2010-11-30

Submissions Property Types

SUPPL

4

Null

7

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76911
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLORAZEPATE DIPOTASSIUM","activeIngredients":"CLORAZEPATE DIPOTASSIUM","strength":"3.75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CLORAZEPATE DIPOTASSIUM","activeIngredients":"CLORAZEPATE DIPOTASSIUM","strength":"7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CLORAZEPATE DIPOTASSIUM","activeIngredients":"CLORAZEPATE DIPOTASSIUM","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLORAZEPATE DIPOTASSIUM","submission":"CLORAZEPATE DIPOTASSIUM","actionType":"3.75MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CLORAZEPATE DIPOTASSIUM","submission":"CLORAZEPATE DIPOTASSIUM","actionType":"7.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CLORAZEPATE DIPOTASSIUM","submission":"CLORAZEPATE DIPOTASSIUM","actionType":"15MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)