ANDA 075058

SUN PHARM INDS INC

FDA Drug Application

Application #075058

Documents

• Letter: 2001-04-27

Application Sponsors

ANDA 075058

SUN PHARM INDS INC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	50MG	0	FLURBIPROFEN	FLURBIPROFEN
002	TABLET;ORAL	100MG	0	FLURBIPROFEN	FLURBIPROFEN

FDA Submissions

	ORIG	1	AP	2001-04-27
LABELING; Labeling	SUPPL	3	AP	2006-06-15
LABELING; Labeling	SUPPL	6	AP	2007-06-19
LABELING; Labeling	SUPPL	7	AP	2007-08-09
LABELING; Labeling	SUPPL	13	AP	2021-04-20	STANDARD
LABELING; Labeling	SUPPL	14	AP	2021-04-30	STANDARD

Submissions Property Types

SUPPL	13	Null	15
SUPPL	14	Null	7

CDER Filings

SUN PHARM INDS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75058
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLURBIPROFEN","activeIngredients":"FLURBIPROFEN","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FLURBIPROFEN","activeIngredients":"FLURBIPROFEN","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLURBIPROFEN","submission":"FLURBIPROFEN","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FLURBIPROFEN","submission":"FLURBIPROFEN","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)