ANDA 077346

SUN PHARM INDS INC

FDA Drug Application

Application #077346

Documents

• Letter: 2007-09-07
• Label: 2007-09-07

Application Sponsors

ANDA 077346

SUN PHARM INDS INC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004

Application Products

001	TABLET;ORAL	6.25MG	0	CARVEDILOL	CARVEDILOL
002	TABLET;ORAL	12.5MG	0	CARVEDILOL	CARVEDILOL
003	TABLET;ORAL	25MG	0	CARVEDILOL	CARVEDILOL
004	TABLET;ORAL	3.125MG	0	CARVEDILOL	CARVEDILOL

FDA Submissions

	ORIG	1	AP	2007-09-05
LABELING; Labeling	SUPPL	4	AP	2009-01-15
LABELING; Labeling	SUPPL	5	AP	2015-04-06
LABELING; Labeling	SUPPL	8	AP	2011-01-31
LABELING; Labeling	SUPPL	11	AP	2013-05-10
LABELING; Labeling	SUPPL	15	AP	2013-05-10
LABELING; Labeling	SUPPL	29	AP	2016-06-01	STANDARD
LABELING; Labeling	SUPPL	30	AP	2016-06-01	STANDARD

Submissions Property Types

SUPPL	5	Null	7
SUPPL	8	Null	8
SUPPL	11	Null	15
SUPPL	15	Null	15
SUPPL	29	Null	7
SUPPL	30	Null	7

CDER Filings

SUN PHARM INDS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77346
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARVEDILOL","activeIngredients":"CARVEDILOL","strength":"6.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CARVEDILOL","activeIngredients":"CARVEDILOL","strength":"12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CARVEDILOL","activeIngredients":"CARVEDILOL","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CARVEDILOL","activeIngredients":"CARVEDILOL","strength":"3.125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/05\/2007","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/077346lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CARVEDILOL","submission":"CARVEDILOL","actionType":"6.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CARVEDILOL","submission":"CARVEDILOL","actionType":"12.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CARVEDILOL","submission":"CARVEDILOL","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CARVEDILOL","submission":"CARVEDILOL","actionType":"3.125MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2007-09-05
        )

)