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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206911
Company: SUN PHARM

Products on NDA 206911

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BROMSITE	BROMFENAC SODIUM	EQ 0.075% ACID	SOLUTION/DROPS;OPHTHALMIC	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206911

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/08/2016	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206911s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206911Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206911Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/09/2023	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206911Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206911Orig1s008ltr.pdf

Labels for NDA 206911

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/09/2023	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206911Orig1s008lbl.pdf
04/08/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206911s000lbl.pdf

Therapeutic Equivalents for NDA 206911

BROMSITE

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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