Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203395
Company: SENTISS

Products on ANDA 203395

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BROMFENAC SODIUM	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT2	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203395

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/22/2014	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 203395

BROMFENAC SODIUM

SOLUTION/DROPS;OPHTHALMIC; EQ 0.09% ACID
TE Code = AT2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BROMFENAC SODIUM	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT2	210560	ALEMBIC
BROMFENAC SODIUM	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT2	204813	EUGIA PHARMA
BROMFENAC SODIUM	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT2	211029	GLAND PHARMA LTD
BROMFENAC SODIUM	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT2	202903	LUPIN LTD
BROMFENAC SODIUM	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT2	203395	SENTISS