ANDA 205540

GLAND PHARMA LTD

FDA Drug Application

Application #205540

Application Sponsors

ANDA 205540

GLAND PHARMA LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	EQ 500MG/20ML (EQ 25MG/ML)	0	LEVOFLOXACIN	LEVOFLOXACIN
002	INJECTABLE;INJECTION	EQ 750MG/30ML (EQ 25MG/ML)	0	LEVOFLOXACIN	LEVOFLOXACIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-04-22

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205540
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOFLOXACIN","activeIngredients":"LEVOFLOXACIN","strength":"EQ 500MG\/20ML (EQ 25MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOFLOXACIN","activeIngredients":"LEVOFLOXACIN","strength":"EQ 750MG\/30ML (EQ 25MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/22\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-04-22
        )

)