Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 204813
Company: EUGIA PHARMA

Products on ANDA 204813

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 204813

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/18/2022	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 204813

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
BROMFENAC SODIUM	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT2	202903	LUPIN
BROMFENAC SODIUM	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT2	203395	SENTISS