Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019807
Company: SANOFI AVENTIS US

Products on NDA 019807

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KERLEDEX	BETAXOLOL HYDROCHLORIDE; CHLORTHALIDONE	5MG;12.5MG	TABLET;ORAL	Discontinued	None	No	No
KERLEDEX	BETAXOLOL HYDROCHLORIDE; CHLORTHALIDONE	10MG;12.5MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019807

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/30/1992	ORIG-1	Approval	Type 4 - New Combination	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/20/2011	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019807s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019807s002ltr.pdf
03/20/2011	SUPPL-1	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019807s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019807s001ltr.pdf

Labels for NDA 019807

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/20/2011	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019807s002lbl.pdf
03/20/2011	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019807s001lbl.pdf