Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203168
Company: BAUSCH AND LOMB

• Summary Review

Products on NDA 203168

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROLENSA	BROMFENAC SODIUM	EQ 0.07% ACID	SOLUTION/DROPS;OPHTHALMIC	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203168

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/05/2013	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203168s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203168Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203168_prolensa_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203168Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/02/2015	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
07/01/2015	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 203168

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/05/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203168s000lbl.pdf

Therapeutic Equivalents for NDA 203168

PROLENSA

SOLUTION/DROPS;OPHTHALMIC; EQ 0.07% ACID
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BROMFENAC SODIUM	BROMFENAC SODIUM	EQ 0.07% ACID	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AB	206027	LUPIN LTD
PROLENSA	BROMFENAC SODIUM	EQ 0.07% ACID	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AB	203168	BAUSCH AND LOMB