BAYSHORE PHARMS LLC FDA Approval ANDA 204059

ANDA 204059

BAYSHORE PHARMS LLC

FDA Drug Application

Application #204059

Application Sponsors

ANDA 204059BAYSHORE PHARMS LLC

Marketing Status

Over-the-counter001

Application Products

001SOLUTION/DROPS;OPHTHALMICEQ 0.025% BASE0KETOTIFEN FUMARATEKETOTIFEN FUMARATE

FDA Submissions

UNKNOWN; ORIG1AP2020-06-01

Submissions Property Types

ORIG1Null7

CDER Filings

BAYSHORE PHARMS LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204059
            [companyName] => BAYSHORE PHARMS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"KETOTIFEN FUMARATE","activeIngredients":"KETOTIFEN FUMARATE","strength":"EQ 0.025% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/01\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-01
        )

)

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