HIKMA FDA Approval ANDA 212286

ANDA 212286

HIKMA

FDA Drug Application

Application #212286

Documents

Letter2020-06-08

Application Sponsors

ANDA 212286HIKMA

Marketing Status

Prescription001

Application Products

001SYRUP;ORAL10MG/5ML0DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-05-22STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAA

CDER Filings

HIKMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212286
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICYCLOMINE HYDROCHLORIDE","activeIngredients":"DICYCLOMINE HYDROCHLORIDE","strength":"10MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/22\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212286Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-22
        )

)

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