MANKIND PHARMA FDA Approval ANDA 216496

ANDA 216496

MANKIND PHARMA

FDA Drug Application

Application #216496

Application Sponsors

ANDA 216496MANKIND PHARMA

Marketing Status

Prescription001

Application Products

001SOLUTION/DROPS;OPHTHALMIC10%0PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2023-01-11STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAT

CDER Filings

MANKIND PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216496
            [companyName] => MANKIND PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENYLEPHRINE HYDROCHLORIDE","activeIngredients":"PHENYLEPHRINE HYDROCHLORIDE","strength":"10%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/11\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2023-01-11
        )

)

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