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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208144
Company: BAUSCH AND LOMB INC

Products on NDA 208144

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208144

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/2017	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208144Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208144Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208144Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2024	SUPPL-17	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208144Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208144Orig1s017ltr.pdf
05/02/2023	SUPPL-15		Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208144Orig1s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208144Orig1s015ltr.pdf
11/29/2021	SUPPL-13	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208144Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208144Orig1s013ltr.pdf
09/23/2020	SUPPL-11	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208144Orig1s011ltr.pdf
03/05/2020	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208144Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208144Orig1s006ltr.pdf
04/30/2019	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208144Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208144Orig1s002ltr.pdf
02/21/2019	SUPPL-1	Manufacturing (CMC)-Facility	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208144Orig1s001lbl_REPLACEMENT.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208144Orig1s001ltr_REPLACEMENT.pdf

Labels for NDA 208144

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2024	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208144Orig1s017lbl.pdf
02/28/2024	SUPPL-17	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208144Orig1s017lbl.pdf
05/02/2023	SUPPL-15	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208144Orig1s015lbl.pdf
11/29/2021	SUPPL-13	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208144Orig1s013lbl.pdf
03/05/2020	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208144Orig1s006lbl.pdf
04/30/2019	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208144Orig1s002lbl.pdf
02/21/2019	SUPPL-1	Manufacturing (CMC)-Facility	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208144Orig1s001lbl_REPLACEMENT.pdf
12/22/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208144Orig1s000lbl.pdf

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

LUMIFY

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

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