ANDA 065154

MAYNE PHARMA

FDA Drug Application

Application #065154

Documents

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

Application Sponsors

ANDA 065154

MAYNE PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

500MG

0

CLARITHROMYCIN

CLARITHROMYCIN

FDA Submissions

	ORIG	1	AP	2005-05-18
LABELING; Labeling	SUPPL	3	AP	2008-06-30
LABELING; Labeling	SUPPL	4	AP	2008-10-22
LABELING; Labeling	SUPPL	5	AP	2010-08-20
LABELING; Labeling	SUPPL	7	AP	2012-03-28
LABELING; Labeling	SUPPL	8	AP	2012-07-19	STANDARD
LABELING; Labeling	SUPPL	9	AP	2012-12-11	STANDARD
LABELING; Labeling	SUPPL	11	AP	2015-12-16	STANDARD
LABELING; Labeling	SUPPL	12	AP	2015-12-16	STANDARD
LABELING; Labeling	SUPPL	13	AP	2015-12-16	STANDARD
LABELING; Labeling	SUPPL	14	AP	2015-12-16	STANDARD

Submissions Property Types

SUPPL	7	Null	15
SUPPL	8	Null	15
SUPPL	9	Null	15
SUPPL	11	Null	7
SUPPL	12	Null	7
SUPPL	13	Null	15
SUPPL	14	Null	15

TE Codes

001

Prescription

AB

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65154
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLARITHROMYCIN","activeIngredients":"CLARITHROMYCIN","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLARITHROMYCIN","submission":"CLARITHROMYCIN","actionType":"500MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)