Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 203324
Company: AVEDRO INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHOTREXA RIBOFLAVIN 5'-PHOSPHATE SODIUM 0.146% SOLUTION/DROPS;OPHTHALMIC Prescription None Yes Yes
PHOTREXA VISCOUS IN DEXTRAN 20% RIBOFLAVIN 5'-PHOSPHATE SODIUM 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

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