Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019807
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
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 |
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 |
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 |