ANDA 090367

CELLTRION

FDA Drug Application

Application #090367

Application Sponsors

ANDA 090367

CELLTRION

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	250MG	0	LEVOFLOXACIN	LEVOFLOXACIN
002	TABLET;ORAL	500MG	0	LEVOFLOXACIN	LEVOFLOXACIN
003	TABLET;ORAL	750MG	0	LEVOFLOXACIN	LEVOFLOXACIN

FDA Submissions

	ORIG	1	AP	2011-06-20
LABELING; Labeling	SUPPL	2	AP	2012-09-24	STANDARD
LABELING; Labeling	SUPPL	3	AP	2015-03-19	STANDARD
LABELING; Labeling	SUPPL	4	AP	2019-05-03	STANDARD
LABELING; Labeling	SUPPL	5	AP	2021-02-11	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	7
SUPPL	4	Null	15
SUPPL	5	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

CELLTRION

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90367
            [companyName] => CELLTRION
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOFLOXACIN","activeIngredients":"LEVOFLOXACIN","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOFLOXACIN","activeIngredients":"LEVOFLOXACIN","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOFLOXACIN","activeIngredients":"LEVOFLOXACIN","strength":"750MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LEVOFLOXACIN","submission":"LEVOFLOXACIN","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVOFLOXACIN","submission":"LEVOFLOXACIN","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVOFLOXACIN","submission":"LEVOFLOXACIN","actionType":"750MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)