Documents
Application Sponsors
Marketing Status
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
TE Codes
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
)
)