ANDA 078767

HIKMA PHARMS

FDA Drug Application

Application #078767

Application Sponsors

ANDA 078767

HIKMA PHARMS

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 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

TA

2011-01-31

Submissions Property Types

ORIG

1

Null

0

CDER Filings

HIKMA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78767
            [companyName] => HIKMA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOFLOXACIN","activeIngredients":"LEVOFLOXACIN","strength":"250MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LEVOFLOXACIN","activeIngredients":"LEVOFLOXACIN","strength":"500MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LEVOFLOXACIN","activeIngredients":"LEVOFLOXACIN","strength":"750MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LEVOFLOXACIN","submission":"LEVOFLOXACIN","actionType":"250MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"LEVOFLOXACIN","submission":"LEVOFLOXACIN","actionType":"500MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"LEVOFLOXACIN","submission":"LEVOFLOXACIN","actionType":"750MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)