ANDA 074980

SUN PHARM INDS LTD

FDA Drug Application

Application #074980

Documents

• Letter: 1998-09-30

Application Sponsors

ANDA 074980

SUN PHARM INDS LTD

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	400MG	0	ACYCLOVIR	ACYCLOVIR
002	TABLET;ORAL	800MG	0	ACYCLOVIR	ACYCLOVIR

FDA Submissions

	ORIG	1	AP	1998-09-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2001-04-18
LABELING; Labeling	SUPPL	3	AP	2001-04-18
LABELING; Labeling	SUPPL	4	AP	2000-09-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2001-04-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2001-04-18
LABELING; Labeling	SUPPL	9	AP	2003-03-18

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74980
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACYCLOVIR","activeIngredients":"ACYCLOVIR","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ACYCLOVIR","activeIngredients":"ACYCLOVIR","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACYCLOVIR","submission":"ACYCLOVIR","actionType":"400MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ACYCLOVIR","submission":"ACYCLOVIR","actionType":"800MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)