ANDA 210183

LUPIN LTD

FDA Drug Application

Application #210183

Documents

• Letter: 2019-08-07

Application Sponsors

ANDA 210183

LUPIN LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;IRRIGATION

EQ 0.3% BASE;EQ 1% BASE

0

KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE

KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-07-01

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AT

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
        )

)