TORRENT FDA Approval ANDA 213542

ANDA 213542

TORRENT

FDA Drug Application

Application #213542

Application Sponsors

ANDA 213542TORRENT

Marketing Status

Prescription001

Application Products

001SOLUTION/DROPS;OPHTHALMIC0.5%0GATIFLOXACINGATIFLOXACIN

FDA Submissions

UNKNOWN; ORIG1AP2021-11-03STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAT

CDER Filings

TORRENT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213542
            [companyName] => TORRENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"GATIFLOXACIN","activeIngredients":"GATIFLOXACIN","strength":"0.5%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/03\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-11-03
        )

)

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