Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 218424
Company: BAUSCH AND LOMB INC

Products on NDA 218424

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LUMIFY PRESERVATIVE FREE	BRIMONIDINE TARTRATE	0.025%	SOLUTION/DROPS;OPHTHALMIC	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 218424

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/19/2024	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218424Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218424Orig1s000ltr.pdf

Labels for NDA 218424

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/19/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218424Orig1s000lbl.pdf

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

LUMIFY PRESERVATIVE FREE

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

SOLUTION/DROPS;OPHTHALMIC; 0.025%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.025%	SOLUTION/DROPS;OPHTHALMIC	Over-the-counter	No	216361	DR REDDYS LABS SA
LUMIFY	BRIMONIDINE TARTRATE	0.025%	SOLUTION/DROPS;OPHTHALMIC	Over-the-counter	Yes	208144	BAUSCH AND LOMB INC
LUMIFY PRESERVATIVE FREE	BRIMONIDINE TARTRATE	0.025%	SOLUTION/DROPS;OPHTHALMIC	Over-the-counter	Yes	218424	BAUSCH AND LOMB INC