LUPIN LTD FDA Approval ANDA 210183

ANDA 210183

LUPIN LTD

FDA Drug Application

Application #210183

Documents

Letter2019-08-07

Application Sponsors

ANDA 210183LUPIN LTD

Marketing Status

Prescription001

Application Products

001SOLUTION;IRRIGATIONEQ 0.3% BASE;EQ 1% BASE0KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDEKETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2019-07-01STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAT

CDER Filings

LUPIN LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210183
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE","activeIngredients":"KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE","strength":"EQ 0.3% BASE;EQ 1% BASE","dosageForm":"SOLUTION;IRRIGATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/01\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210183Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-07-01
        )

)

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