Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219219
Company: GLAND

Products on ANDA 219219

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219219

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/11/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219219

BRIMONIDINE TARTRATE

SOLUTION/DROPS;OPHTHALMIC; 0.1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALPHAGAN P	BRIMONIDINE TARTRATE	0.1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AB	021770	ABBVIE
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AB	216909	ALEMBIC
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AB	078480	APOTEX
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AB	219219	GLAND
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AB	213215	LUPIN LTD
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AB	203172	SANDOZ
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AB	216906	SOMERSET THERAPS LLC