Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076260
Company: BAUSCH AND LOMB INC

Products on ANDA 076260

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076260

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/28/2003	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 076260

BRIMONIDINE TARTRATE

SOLUTION/DROPS;OPHTHALMIC; 0.2%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	076260	BAUSCH AND LOMB INC
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	217846	MICRO LABS
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	091691	REGCON HOLDINGS
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	076439	RISING
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	076254	SANDOZ
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	078075	SANDOZ
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	208992	SOMERSET THERAPS LLC