ANDA 065145

ACTAVIS LABS FL INC

FDA Drug Application

Application #065145

Documents

• Other Important Information from FDA: 2006-03-03

Application Sponsors

ANDA 065145

ACTAVIS LABS FL INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

500MG

0

CLARITHROMYCIN

CLARITHROMYCIN

FDA Submissions

	ORIG	1	AP	2004-06-24
LABELING; Labeling	SUPPL	7	AP	2006-05-10
LABELING; Labeling	SUPPL	10	AP	2008-01-30
LABELING; Labeling	SUPPL	21	AP	2010-03-10
LABELING; Labeling	SUPPL	25	AP	2011-07-07
LABELING; Labeling	SUPPL	30	AP	2012-12-11	STANDARD
LABELING; Labeling	SUPPL	31	AP	2015-03-02	STANDARD
LABELING; Labeling	SUPPL	33	AP	2015-03-02	STANDARD
LABELING; Labeling	SUPPL	34	AP	2015-03-02	STANDARD

Submissions Property Types

SUPPL	21	Null	7
SUPPL	30	Null	15
SUPPL	31	Null	15
SUPPL	33	Null	7
SUPPL	34	Null	15

TE Codes

001

Prescription

AB

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65145
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLARITHROMYCIN","activeIngredients":"CLARITHROMYCIN","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLARITHROMYCIN","submission":"CLARITHROMYCIN","actionType":"500MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)