Home Applications 022064 Application 022064
Type NDA
Sponsor SANOFI AVENTIS US Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 XYZAL LEVOCETIRIZINE DIHYDROCHLORIDE TABLET;ORAL 5MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022064-001 XYZAL LEVOCETIRIZINE DIHYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-05-25
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 2 · 44 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UTC 2022-10 N022064-001 XYZAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-05-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022064-001 XYZAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-05-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022064-001 XYZAL 5MG TABLET / ORAL RLD 2007-05-25 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N022064-001 XYZAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-05-25 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Xyzal LEVOCETIRIZINE DIHYDROCHLORIDE Chattem, Inc. 1673f7ff-0c7c-4403-86cf-c05eb1475222 2025-07-22 Warnings, Adverse reactions Exact identifier application applno (NDA): 022064 application number: NDA022064
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0024-5803 Xyzal levocetirizine dihydrochloride Sanofi-Aventis U.S. LLC NDA Current 0024-5803 Xyzal levocetirizine dihydrochloride Sanofi-Aventis U.S. LLC NDA Current 0024-5803 Xyzal levocetirizine dihydrochloride Sanofi-Aventis U.S. LLC NDA Current