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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022308
Company: BAUSCH AND LOMB

Summary Review

Products on NDA 022308

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BESIVANCE	BESIFLOXACIN HYDROCHLORIDE	EQ 0.6% BASE	SUSPENSION/DROPS;OPHTHALMIC	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022308

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/28/2009	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/2009/022308lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022308s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022308s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022308s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/03/2018	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022308s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022308s013ltr.pdf
11/10/2015	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
04/07/2015	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
09/05/2014	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
04/30/2014	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
11/14/2013	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
05/10/2013	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
08/16/2013	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
09/18/2012	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022308s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022308Orig1s003ltr.pdf

Labels for NDA 022308

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/03/2018	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022308s013lbl.pdf
09/18/2012	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022308s003lbl.pdf
05/28/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022308lbl.pdf

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