Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 203324
Company: GLAUKOS
Company: GLAUKOS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PHOTREXA | RIBOFLAVIN 5'-PHOSPHATE | 0.146% | SOLUTION/DROPS;OPHTHALMIC | Prescription | None | Yes | Yes |
PHOTREXA VISCOUS IN DEXTRAN 20% | RIBOFLAVIN 5'-PHOSPHATE | 0.146% | SOLUTION/DROPS;OPHTHALMIC | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
07/15/2016 | ORIG-2 | Approval | Efficacy | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203324s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203324Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/203324Orig2s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/203324Orig2s000SumR.pdf | |
04/15/2016 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203324s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203324Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/203324Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/203324Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/29/2018 | SUPPL-7 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
01/25/2019 | SUPPL-6 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203324s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203324Orig1s006ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/25/2019 | SUPPL-6 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203324s006lbl.pdf | |
07/15/2016 | ORIG-2 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203324s000lbl.pdf | |
04/15/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203324s000lbl.pdf |