UPSHER SMITH LABS FDA Approval ANDA 212616

ANDA 212616

UPSHER SMITH LABS

FDA Drug Application

Application #212616

Application Sponsors

ANDA 212616UPSHER SMITH LABS

Marketing Status

Prescription001

Application Products

001SOLUTION/DROPS;OPHTHALMICEQ 0.5% BASE0MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-02-10STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAT1

CDER Filings

UPSHER SMITH LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212616
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MOXIFLOXACIN HYDROCHLORIDE","activeIngredients":"MOXIFLOXACIN HYDROCHLORIDE","strength":"EQ 0.5% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/10\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-10
        )

)

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