Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022288
Company: BAUSCH AND LOMB INC

• Summary Review

Products on NDA 022288

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BEPREVE	BEPOTASTINE BESILATE	1.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022288

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/08/2009	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022288lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022288s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022288s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022288s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/09/2018	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022288s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022288Orig1s008ltr.pdf
02/05/2016	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
06/28/2012	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022288s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022288s003ltr.pdf

Labels for NDA 022288

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/09/2018	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022288s008lbl.pdf
06/28/2012	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022288s003lbl.pdf
09/08/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022288lbl.pdf

Therapeutic Equivalents for NDA 022288

BEPREVE

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