AKORN FDA Approval ANDA 205309

ANDA 205309

AKORN

FDA Drug Application

Application #205309

Documents

Letter2016-10-05

Application Sponsors

ANDA 205309AKORN

Marketing Status

Prescription001
Prescription002

Application Products

001SOLUTION/DROPS;OPHTHALMICEQ 0.25% BASE0TIMOLOLTIMOLOL
002SOLUTION/DROPS;OPHTHALMICEQ 0.5% BASE0TIMOLOLTIMOLOL

FDA Submissions

UNKNOWN; ORIG1AP2016-09-30STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAT
002PrescriptionAT

CDER Filings

AKORN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205309
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"TIMOLOL","activeIngredients":"TIMOLOL","strength":"EQ 0.25% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TIMOLOL","activeIngredients":"TIMOLOL","strength":"EQ 0.5% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/30\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205309Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-09-30
        )

)

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