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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216909
Company: ALEMBIC

Products on ANDA 216909

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 216909

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/01/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216909

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	203172	SANDOZ

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