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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021664
Company: BAUSCH AND LOMB INC

Products on NDA 021664

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BROMDAY	BROMFENAC SODIUM	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	Yes	No
XIBROM	BROMFENAC SODIUM	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021664

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/24/2005	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021664lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021664ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021664s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/11/2014	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
01/27/2014	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021664s014s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021664Orig1s014,s019ltr.pdf
01/27/2014	SUPPL-14	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021664s014s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021664Orig1s014,s019ltr.pdf
10/16/2010	SUPPL-13	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021664s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021664s013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021664Orig1s013.pdf
06/02/2009	SUPPL-10	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021664s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021664s010ltr.pdf
01/27/2006	SUPPL-1	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021664s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021664s001ltr.pdf

Labels for NDA 021664

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/27/2014	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021664s014s019lbl.pdf
01/27/2014	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021664s014s019lbl.pdf
10/16/2010	SUPPL-13	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021664s013lbl.pdf
06/02/2009	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021664s010lbl.pdf
01/27/2006	SUPPL-1	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021664s001lbl.pdf
03/24/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021664lbl.pdf

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