ANDA 075423

SUN PHARM INDS INC

FDA Drug Application

Application #075423

Documents

• Letter: 2001-04-27

Application Sponsors

ANDA 075423

SUN PHARM INDS INC

Marketing Status

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

Application Products

001	TABLET;ORAL	0.5MG	0	CLONAZEPAM	CLONAZEPAM
002	TABLET;ORAL	1MG	0	CLONAZEPAM	CLONAZEPAM
003	TABLET;ORAL	2MG	0	CLONAZEPAM	CLONAZEPAM

FDA Submissions

	ORIG	1	AP	2001-04-27
LABELING; Labeling	SUPPL	2	AP	2003-02-20
LABELING; Labeling	SUPPL	6	AP	2005-09-15
LABELING; Labeling	SUPPL	13	AP	2009-11-02
LABELING; Labeling	SUPPL	14	AP	2011-04-08
REMS; REMS	SUPPL	15	AP	2011-04-08
LABELING; Labeling	SUPPL	19	AP	2012-06-20	STANDARD

Submissions Property Types

SUPPL	13	Null	7
SUPPL	19	Null	8

CDER Filings

SUN PHARM INDS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75423
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLONAZEPAM","activeIngredients":"CLONAZEPAM","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CLONAZEPAM","activeIngredients":"CLONAZEPAM","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CLONAZEPAM","activeIngredients":"CLONAZEPAM","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLONAZEPAM","submission":"CLONAZEPAM","actionType":"0.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CLONAZEPAM","submission":"CLONAZEPAM","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CLONAZEPAM","submission":"CLONAZEPAM","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)