Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | SOLUTION/DROPS;OPHTHALMIC | 0.146% | 1 | PHOTREXA | RIBOFLAVIN 5'-PHOSPHATE SODIUM |
| 002 | SOLUTION/DROPS;OPHTHALMIC | 0.146% | 1 | PHOTREXA VISCOUS IN DEXTRAN 20% | RIBOFLAVIN 5'-PHOSPHATE SODIUM |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2016-04-15 | PRIORITY |
| EFFICACY; Efficacy | ORIG | 2 | AP | 2016-07-15 | PRIORITY |
| LABELING; Labeling | SUPPL | 6 | AP | 2019-01-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2018-10-29 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| ORIG | 2 | Null | 6 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 7 | Null | 15 |
CDER Filings
GLAUKOS
cder:Array
(
[0] => Array
(
[ApplNo] => 203324
[companyName] => GLAUKOS
[docInserts] => ["",""]
[products] => [{"drugName":"PHOTREXA","activeIngredients":"RIBOFLAVIN 5'-PHOSPHATE SODIUM","strength":"0.146%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"PHOTREXA VISCOUS IN DEXTRAN 20%","activeIngredients":"RIBOFLAVIN 5'-PHOSPHATE SODIUM","strength":"0.146%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"01\/25\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203324s006lbl.pdf\"}]","notes":""},{"actionDate":"07\/15\/2016","submission":"ORIG-2","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203324s000lbl.pdf\"}]","notes":""},{"actionDate":"04\/15\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203324s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"07\/15\/2016","submission":"ORIG-2","actionType":"Approval","submissionClassification":"Efficacy","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203324s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/203324Orig2s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/203324Orig2s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/203324Orig2s000SumR.pdf\"}]","notes":">"},{"actionDate":"04\/15\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203324s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/203324Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/203324Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/203324Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"10\/29\/2018","submission":"SUPPL-7","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/25\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203324s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/203324Orig1s006ltr.pdf\"}]","notes":">"}]
[actionDate] => 2019-01-25
)
)