Home Applications 019807 Application 019807
Type NDA
Sponsor SANOFI AVENTIS US Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 KERLEDEX BETAXOLOL HYDROCHLORIDE; CHLORTHALIDONE TABLET;ORAL 5MG;12.5MG No No 002 KERLEDEX BETAXOLOL HYDROCHLORIDE; CHLORTHALIDONE TABLET;ORAL 10MG;12.5MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019807-001 KERLEDEX BETAXOLOL HYDROCHLORIDE; CHLORTHALIDONE 5MG;12.5MG TABLET / ORAL 1992-10-30 N019807-002 KERLEDEX BETAXOLOL HYDROCHLORIDE; CHLORTHALIDONE 10MG;12.5MG TABLET / ORAL 1992-10-30
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 3 of 3 · 88 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 N019807-001 KERLEDEX 5MG;12.5MG TABLET / ORAL 1992-10-30 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N019807-002 KERLEDEX 10MG;12.5MG TABLET / ORAL 1992-10-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019807-001 KERLEDEX 5MG;12.5MG TABLET / ORAL 1992-10-30 e64feba35796…2022-09-29 23:25 UTC 2022-09 N019807-002 KERLEDEX 10MG;12.5MG TABLET / ORAL 1992-10-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019807-001 KERLEDEX 5MG;12.5MG TABLET / ORAL 1992-10-30 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019807-002 KERLEDEX 10MG;12.5MG TABLET / ORAL 1992-10-30 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N019807-001 KERLEDEX 5MG;12.5MG TABLET / ORAL 1992-10-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N019807-002 KERLEDEX 10MG;12.5MG TABLET / ORAL 1992-10-30 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 19229 SUPPL 2011-08-24 11726 SUPPL 2011-08-24 33959 SUPPL 2011-03-28 1630 SUPPL 2011-03-24