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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078479
Company: APOTEX

Products on ANDA 078479

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 078479

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/31/2022	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/078479Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 078479

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

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