Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206066
Company: APOTEX

Products on ANDA 206066

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BEPOTASTINE BESILATE	BEPOTASTINE BESILATE	1.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206066

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/05/2019	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206066Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 206066

BEPOTASTINE BESILATE

SOLUTION/DROPS;OPHTHALMIC; 1.5%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BEPOTASTINE BESILATE	BEPOTASTINE BESILATE	1.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	214588	ALEMBIC
BEPOTASTINE BESILATE	BEPOTASTINE BESILATE	1.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	206066	APOTEX
BEPOTASTINE BESILATE	BEPOTASTINE BESILATE	1.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	206220	MYLAN
BEPREVE	BEPOTASTINE BESILATE	1.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT	022288	BAUSCH AND LOMB INC