An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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
QOLIANA	BRIMONIDINE TARTRATE	0.15%	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT	021764	SANDOZ

Top