Application Sponsors
ANDA 202077 | DR REDDYS LABS LTD | |
Marketing Status
Application Products
001 | SOLUTION/DROPS;OPHTHALMIC | 0.005% | 0 | LATANOPROST | LATANOPROST |
FDA Submissions
N/A; Not Applicable | ORIG | 1 | AP | 2013-02-11 | |
| SUPPL | 11 | AP | 2013-02-11 | |
Submissions Property Types
TE Codes
CDER Filings
DR REDDYS LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 202077
[companyName] => DR REDDYS LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"LATANOPROST","activeIngredients":"LATANOPROST","strength":"0.005%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/11\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"02\/11\/2013","submission":"SUPPL-11","supplementCategories":"","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/17\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2015-12-17
)
)