PADAGIS US FDA Approval ANDA 212715

ANDA 212715

PADAGIS US

FDA Drug Application

Application #212715

Application Sponsors

ANDA 212715PADAGIS US

Marketing Status

Prescription001

Application Products

001SUSPENSION/DROPS;OPHTHALMIC0.1%;0.3%0TOBRAMYCIN AND DEXAMETHASONEDEXAMETHASONE; TOBRAMYCIN

FDA Submissions

UNKNOWN; ORIG1AP2022-02-11STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

PADAGIS US
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212715
            [companyName] => PADAGIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOBRAMYCIN AND DEXAMETHASONE","activeIngredients":"DEXAMETHASONE; TOBRAMYCIN","strength":"0.1%;0.3%","dosageForm":"SUSPENSION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TOBRAMYCIN AND DEXAMETHASONE","submission":"DEXAMETHASONE; TOBRAMYCIN","actionType":"0.1%;0.3%","submissionClassification":"SUSPENSION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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