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 2 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 2019-12-13 00:20 UTC 2019-12 N019807-001 KERLEDEX 5MG;12.5MG TABLET / ORAL 1992-10-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019807-002 KERLEDEX 10MG;12.5MG TABLET / ORAL 1992-10-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019807-001 KERLEDEX 5MG;12.5MG TABLET / ORAL 1992-10-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N019807-002 KERLEDEX 10MG;12.5MG TABLET / ORAL 1992-10-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019807-001 KERLEDEX 5MG;12.5MG TABLET / ORAL 1992-10-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N019807-002 KERLEDEX 10MG;12.5MG TABLET / ORAL 1992-10-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019807-001 KERLEDEX 5MG;12.5MG TABLET / ORAL 1992-10-30 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019807-002 KERLEDEX 10MG;12.5MG TABLET / ORAL 1992-10-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019807-001 KERLEDEX 5MG;12.5MG TABLET / ORAL 1992-10-30 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N019807-002 KERLEDEX 10MG;12.5MG TABLET / ORAL 1992-10-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019807-001 KERLEDEX 5MG;12.5MG TABLET / ORAL 1992-10-30 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N019807-002 KERLEDEX 10MG;12.5MG TABLET / ORAL 1992-10-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019807-001 KERLEDEX 5MG;12.5MG TABLET / ORAL 1992-10-30 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N019807-002 KERLEDEX 10MG;12.5MG TABLET / ORAL 1992-10-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019807-001 KERLEDEX 5MG;12.5MG TABLET / ORAL 1992-10-30 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N019807-002 KERLEDEX 10MG;12.5MG TABLET / ORAL 1992-10-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019807-001 KERLEDEX 5MG;12.5MG TABLET / ORAL 1992-10-30 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N019807-002 KERLEDEX 10MG;12.5MG TABLET / ORAL 1992-10-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019807-001 KERLEDEX 5MG;12.5MG TABLET / ORAL 1992-10-30 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N019807-002 KERLEDEX 10MG;12.5MG TABLET / ORAL 1992-10-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019807-001 KERLEDEX 5MG;12.5MG TABLET / ORAL 1992-10-30 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019807-002 KERLEDEX 10MG;12.5MG TABLET / ORAL 1992-10-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019807-001 KERLEDEX 5MG;12.5MG TABLET / ORAL 1992-10-30 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N019807-002 KERLEDEX 10MG;12.5MG TABLET / ORAL 1992-10-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019807-001 KERLEDEX 5MG;12.5MG TABLET / ORAL 1992-10-30 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N019807-002 KERLEDEX 10MG;12.5MG TABLET / ORAL 1992-10-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019807-001 KERLEDEX 5MG;12.5MG TABLET / ORAL 1992-10-30 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019807-002 KERLEDEX 10MG;12.5MG TABLET / ORAL 1992-10-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019807-001 KERLEDEX 5MG;12.5MG TABLET / ORAL 1992-10-30 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019807-002 KERLEDEX 10MG;12.5MG TABLET / ORAL 1992-10-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019807-001 KERLEDEX 5MG;12.5MG TABLET / ORAL 1992-10-30 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019807-002 KERLEDEX 10MG;12.5MG TABLET / ORAL 1992-10-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019807-001 KERLEDEX 5MG;12.5MG TABLET / ORAL 1992-10-30 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019807-002 KERLEDEX 10MG;12.5MG TABLET / ORAL 1992-10-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019807-001 KERLEDEX 5MG;12.5MG TABLET / ORAL 1992-10-30 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N019807-002 KERLEDEX 10MG;12.5MG TABLET / ORAL 1992-10-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019807-001 KERLEDEX 5MG;12.5MG TABLET / ORAL 1992-10-30 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N019807-002 KERLEDEX 10MG;12.5MG TABLET / ORAL 1992-10-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019807-001 KERLEDEX 5MG;12.5MG TABLET / ORAL 1992-10-30 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019807-002 KERLEDEX 10MG;12.5MG TABLET / ORAL 1992-10-30 3a93d1ddd44b…
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