Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 218010
Company: GLAUKOS

Products on NDA 218010

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IDOSE TR	TRAVOPROST	75MCG	IMPLANT;INTRACAMERAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 218010

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/13/2023	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/218010s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/218010Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/218010Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/27/2026	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218010Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/218010Orig1s006ltr.pdf
01/27/2026	SUPPL-4	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218010s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/218010Orig1s004ltr.pdf

Labels for NDA 218010

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/27/2026	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218010Orig1s006lbl.pdf
01/27/2026	SUPPL-4	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218010s004lbl.pdf
12/13/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/218010s000lbl.pdf