HI TECH FDA Approval ANDA 207609

ANDA 207609

HI TECH

FDA Drug Application

Application #207609

Documents

Letter2019-05-21

Application Sponsors

ANDA 207609HI TECH

Marketing Status

Prescription001

Application Products

001SUSPENSION/DROPS;OPHTHALMIC0.5%0LOTEPREDNOL ETABONATELOTEPREDNOL ETABONATE

FDA Submissions

UNKNOWN; ORIG1AP2019-04-17STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

HI TECH
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207609
            [companyName] => HI TECH
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOTEPREDNOL ETABONATE","activeIngredients":"LOTEPREDNOL ETABONATE","strength":"0.5%","dosageForm":"SUSPENSION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/17\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/207609Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-04-17
        )

)

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