Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021114
Company: ALCON PHARMS LTD

Products on NDA 021114

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BETAXON	LEVOBETAXOLOL HYDROCHLORIDE	EQ 0.5% BASE	SUSPENSION/DROPS;OPHTHALMIC	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021114

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/23/2000	ORIG-1	Approval	Type 2 - New Active Ingredient	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21114lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/021114_Betaxon_approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021114_s000_Betaxon.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/11/2006	SUPPL-11	Labeling		Label is not available on this site.
03/09/2010	SUPPL-3	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021114s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021114s003ltr.pdf
09/28/2006	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021114s002LTR.pdf

Labels for NDA 021114

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/09/2010	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021114s003lbl.pdf
02/23/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21114lbl.pdf