Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216772
Company: UPSHER SMITH LABS

Products on ANDA 216772

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.15%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216772

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/12/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/05/2026	SUPPL-2	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 216772

BRIMONIDINE TARTRATE

SOLUTION/DROPS;OPHTHALMIC; 0.15%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALPHAGAN P	BRIMONIDINE TARTRATE	0.15%	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT	021262	ABBVIE
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.15%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	215225	ALEMBIC
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.15%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	078479	APOTEX
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.15%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	216772	UPSHER SMITH LABS
QOLIANA	BRIMONIDINE TARTRATE	0.15%	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT	021764	SANDOZ