Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208254
Company: ALCON LABS INC

Products on NDA 208254

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RHOPRESSA	NETARSUDIL MESYLATE	EQ 0.02% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208254

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/18/2017	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		httpS://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208254lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208254Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208254Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/18/2024	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208254s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208254Orig1s014ltr.pdf
03/22/2019	SUPPL-3	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208254s003lbl.pdf

Labels for NDA 208254

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/18/2024	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208254s014lbl.pdf
03/22/2019	SUPPL-3	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208254s003lbl.pdf
12/18/2017	ORIG-1	Approval	Label (PDF)		httpS://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208254lbl.pdf