DR REDDYS LABS LTD FDA Approval ANDA 205548

ANDA 205548

DR REDDYS LABS LTD

FDA Drug Application

Application #205548

Documents

Letter2020-09-18

Application Sponsors

ANDA 205548DR REDDYS LABS LTD

Marketing Status

Prescription001

Application Products

001SUSPENSION/DROPS;OTIC0.3%;0.1%0CIPROFLOXACIN AND DEXAMETHASONECIPROFLOXACIN; DEXAMETHASONE

FDA Submissions

UNKNOWN; ORIG1AP2020-08-10STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

DR REDDYS LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205548
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CIPROFLOXACIN AND DEXAMETHASONE","activeIngredients":"CIPROFLOXACIN; DEXAMETHASONE","strength":"0.3%;0.1%","dosageForm":"SUSPENSION\/DROPS;OTIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/10\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-10
        )

)

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