ANDA 075270

ACTAVIS LABS FL INC

FDA Drug Application

Application #075270

Documents

• Letter: 1999-03-24

Application Sponsors

ANDA 075270

ACTAVIS LABS FL INC

Marketing Status

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

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	200MG	0	KETOPROFEN	KETOPROFEN
002	CAPSULE, EXTENDED RELEASE;ORAL	100MG	0	KETOPROFEN	KETOPROFEN
003	CAPSULE, EXTENDED RELEASE;ORAL	150MG	0	KETOPROFEN	KETOPROFEN

FDA Submissions

	ORIG	1	AP	1999-03-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-09-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-12-24
LABELING; Labeling	SUPPL	7	AP	2006-07-03
LABELING; Labeling	SUPPL	8	AP	2006-09-22
LABELING; Labeling	SUPPL	10	AP	2008-02-21
LABELING; Labeling	SUPPL	13	AP	2016-05-09	STANDARD
LABELING; Labeling	SUPPL	14	AP	2021-04-28	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	13	Null	15
SUPPL	14	Null	7

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75270
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"KETOPROFEN","activeIngredients":"KETOPROFEN","strength":"200MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"KETOPROFEN","activeIngredients":"KETOPROFEN","strength":"100MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"KETOPROFEN","activeIngredients":"KETOPROFEN","strength":"150MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"KETOPROFEN","submission":"KETOPROFEN","actionType":"200MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"KETOPROFEN","submission":"KETOPROFEN","actionType":"100MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"KETOPROFEN","submission":"KETOPROFEN","actionType":"150MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)