ANDA 205833

MYLAN LABS LTD

FDA Drug Application

Application #205833

Application Sponsors

ANDA 205833

MYLAN LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

400MG/250ML (1.6MG/ML)

0

MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

MOXIFLOXACIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-05-05	STANDARD
LABELING; Labeling	SUPPL	3	AP	2018-10-18	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-05-03	STANDARD
LABELING; Labeling	SUPPL	6	AP	2019-04-30	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-12-04	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	7
SUPPL	5	Null	7
SUPPL	6	Null	7
SUPPL	8	Null	7

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205833
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER","activeIngredients":"MOXIFLOXACIN HYDROCHLORIDE","strength":"400MG\/250ML (1.6MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/05\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/04\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/30\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/03\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/18\/2018","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-12-04
        )

)