Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019507
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KERLONE BETAXOLOL HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
KERLONE BETAXOLOL HYDROCHLORIDE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/27/1989 ORIG-1 Approval Type 3 - New Dosage Form 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
08/17/2011 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019507s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019507s008ltr.pdf
05/12/2009 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019507s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019507s007ltr.pdf
08/06/2008 SUPPL-6 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019507s006ltr.pdf
01/27/1995 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/01/1992 SUPPL-4 Labeling

Label is not available on this site.

10/26/1990 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

07/05/1990 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/17/2011 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019507s008lbl.pdf
05/12/2009 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019507s007lbl.pdf

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