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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203324
Company: GLAUKOS

Summary Review

Products on NDA 203324

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203324

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

Labels for NDA 203324

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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