Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 220341
Company: ALCON LABORATORIES, INC.

Products on NDA 220341

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BRYTLY	BRYTLY (APRACLONIDINE)	0.125%	SOLUTION/ DROPS	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 220341

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/16/2026	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220341Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/220341Orig1s000ltr.pdf

Labels for NDA 220341

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/16/2026	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220341Orig1s000lbl.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

BRYTLY

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SOLUTION/ DROPS; 0.125%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
BRYTLY	BRYTLY (APRACLONIDINE)	0.125%	SOLUTION/ DROPS	Over-the-counter	No	220341	ALCON LABORATORIES, INC.