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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211239
Company: LUPIN LTD

Products on ANDA 211239

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BROMFENAC SODIUM	BROMFENAC SODIUM	EQ 0.075% ACID	SOLUTION/DROPS;OPHTHALMIC	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211239

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/02/2024	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/211239Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 211239

BROMFENAC SODIUM

SOLUTION/DROPS;OPHTHALMIC; EQ 0.075% 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 0.075% ACID	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AB	211239	LUPIN LTD
BROMSITE	BROMFENAC SODIUM	EQ 0.075% ACID	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AB	206911	SUN PHARM

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