Documents
Application Sponsors
Marketing Status
Application Products
001 | SOLUTION/DROPS;OPHTHALMIC | 0.004% | 0 | TRAVOPROST | TRAVOPROST |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2015-07-10 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2020-01-27 | UNKNOWN |
LABELING; Labeling | SUPPL | 10 | AP | 2020-09-03 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 19 |
SUPPL | 5 | Null | 7 |
SUPPL | 10 | Null | 15 |
TE Codes
CDER Filings
APOTEX
cder:Array
(
[0] => Array
(
[ApplNo] => 203431
[companyName] => APOTEX
[docInserts] => ["",""]
[products] => [{"drugName":"TRAVOPROST","activeIngredients":"TRAVOPROST","strength":"0.004%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/10\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203431Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"09\/03\/2020","submission":"SUPPL-10","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/27\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/27\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-09-03
)
)