FDA.reportPublic FDA data

Application 022157

Type
NDA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XYZALLEVOCETIRIZINE DIHYDROCHLORIDESOLUTION;ORAL2.5MG/5MLYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022157-001XYZALLEVOCETIRIZINE DIHYDROCHLORIDE2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2008-01-28

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 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N022157-001XYZAL2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2008-01-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022157-001XYZAL2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2008-01-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022157-001XYZAL2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2008-01-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N022157-001XYZAL2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2008-01-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022157-001XYZAL2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2008-01-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022157-001XYZAL2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2008-01-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022157-001XYZAL2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2008-01-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022157-001XYZAL2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2008-01-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022157-001XYZAL2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2008-01-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022157-001XYZAL2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2008-01-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022157-001XYZAL2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2008-01-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022157-001XYZAL2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2008-01-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022157-001XYZAL2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2008-01-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022157-001XYZAL2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2008-01-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022157-001XYZAL2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2008-01-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022157-001XYZAL2.5MG/5MLSOLUTION / ORALRLD2008-01-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022157-001XYZAL2.5MG/5MLSOLUTION / ORALRLD2008-01-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022157-001XYZAL2.5MG/5MLSOLUTION / ORALRLD2008-01-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022157-001XYZAL2.5MG/5MLSOLUTION / ORALAARLD2008-01-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022157-001XYZAL2.5MG/5MLSOLUTION / ORALRLD2008-01-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022157-001XYZAL2.5MG/5MLSOLUTION / ORALRLD2008-01-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022157-001XYZAL2.5MG/5MLSOLUTION / ORALAARLD2008-01-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N022157-001XYZAL2.5MG/5MLSOLUTION / ORALAARLD2008-01-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022157-001XYZAL2.5MG/5MLSOLUTION / ORALAARLD2008-01-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022157-001XYZAL2.5MG/5MLSOLUTION / ORALAARLD2008-01-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022157-001XYZAL2.5MG/5MLSOLUTION / ORALAARLD2008-01-283f01610625f2…
2019-09-15 20:21 UTC2019-09N022157-001XYZAL2.5MG/5MLSOLUTION / ORALAARLD2008-01-28b00525d2431f…
2019-07-19 19:46 UTC2019-07N022157-001XYZAL2.5MG/5MLSOLUTION / ORALAARLD2008-01-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022157-001XYZAL2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2008-01-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022157-001XYZAL2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2008-01-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022157-001XYZAL2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2008-01-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022157-001XYZAL2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2008-01-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022157-001XYZAL2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2008-01-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022157-001XYZAL2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2008-01-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022157-001XYZAL2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2008-01-283f0d92c62455…
2023-05-13 08:27 UTC2023-05N022157-001XYZAL2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2008-01-28053a50430f4f…
2023-01-26 05:58 UTC2023-01N022157-001XYZAL2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2008-01-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022157-001XYZAL2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2008-01-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022157-001XYZAL2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2008-01-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022157-001XYZAL2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2008-01-28e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N022157-001AA174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022157-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03N022157-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022157-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022157-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022157-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09N022157-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07N022157-001AA1ea99ee380514…

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 4 · 75 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEGolden State Medical Supply, Inc.163dcce7-4535-a596-e063-6394a90a634f2026-08-13Warnings, Adverse reactionsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
good sense levocetirizineLEVOCETIRIZINE DIHYDROCHLORIDEL. Perrigo Company0b482364-a00a-4b95-975a-f403a3ae4d2e2026-07-13WarningsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEDr. Reddy's Laboratories Inc.1f722b84-08de-7e6a-41ac-2c9d9bb9fb432026-06-04WarningsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEBryant Ranch Prepack8274ca80-e7d3-4f4f-9901-cc5c589b4fef2026-05-21Warnings, Adverse reactionsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEBryant Ranch Prepackbe58ca52-ab5d-4656-bfe0-bd57662359682026-05-15Warnings, Adverse reactionsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEFarmacias De Similares TX LLC4ed17484-5609-d993-e063-6294a90a82a22026-04-06WarningsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEBryant Ranch Prepackc79d3668-5243-4627-ad2b-cc7c045df1202026-03-31Warnings, Adverse reactionsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDENuCare Pharmaceuticals,Inc.c2dbf151-5b3d-5dfb-e053-2995a90a4c192026-03-25Warnings, Adverse reactionsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEA-S Medication Solutionsd8b4b326-8be1-4404-9db7-636d869331392026-03-24Warnings, Adverse reactionsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Xyzal Allergy 24HRLEVOCETIRIZINE DIHYDROCHLORIDEChattem, Inc.8be45c2a-1eca-4a00-81b9-f7babdbdcd412026-03-11WarningsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDESportpharm LLC8c00c74f-4377-4f2c-943e-e55afa5a824f2026-02-14Name fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Childrens Xyzal AllergyLEVOCETIRIZINE DIHYDROCHLORIDEChattem, Inc.a33f2704-d350-428b-b467-91f4775ce17f2026-02-05WarningsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDEGlenmark Pharmaceuticals Inc., USA60ae7e0e-281c-40a3-a0d3-259b843ddaaa2026-01-22Warnings, Adverse reactionsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEKROGER COMPANYe47658af-e0f3-5765-f568-300ba407dc292026-01-20WarningsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDECVS PHARMACYc8681ca3-27b4-6738-af72-599ff05f2ec82026-01-20WarningsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEWalgreens Company766b8836-74b8-8af7-b900-b813b4fc175b2026-01-20WarningsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
24HR Allergy ReliefLEVOCETIRIZINE DIHYDROCHLORIDELEADER/ Cardinal Health 110, Inc.6ba57f12-fd25-c4a6-ff2d-2955116f84c42026-01-20WarningsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Allergy ReliefLEVOCETIRIZINE DIHYDROCHLORIDEAlbertsons Companiese1a6932b-d076-6573-5b88-7b06c3a916812026-01-20WarningsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDESAM'S WEST INCbb8d38b2-117a-fc6b-4ba0-0bc0188cbcd12026-01-19WarningsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDETarget Corporation7e933c85-96b0-b103-e26a-1aa8a1ded58e2026-01-19WarningsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0024-5804Xyzallevocetirizine dihydrochlorideSanofi-Aventis U.S. LLCNDACurrent
0024-5804Xyzallevocetirizine dihydrochlorideSanofi-Aventis U.S. LLCNDACurrent
0024-5804Xyzallevocetirizine dihydrochlorideSanofi-Aventis U.S. LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82833SUPPL 2025-07-14
82829SUPPL 2025-07-14
58215SUPPL2019-04-04
58196SUPPL2019-04-03
57255SUPPL2019-01-18
57233SUPPL2019-01-16
53594SUPPL2018-04-03
53593SUPPL2018-04-03
50109SUPPL2017-10-19
50064SUPPL2017-10-17
48969SUPPL2017-07-13
48964SUPPL2017-07-13
47235SUPPL2017-02-16
47167SUPPL2017-02-10
45860SUPPL2016-11-09
45857SUPPL2016-11-09
17033SUPPL2016-06-27
29337SUPPL2016-06-24
17032SUPPL2013-11-08
6984SUPPL2013-11-08
38317SUPPL2012-09-11
29336SUPPL2012-09-07
6983SUPPL2011-03-10
17031SUPPL2011-03-07
44687ORIG2010-04-01
42433ORIG2010-04-01
6982SUPPL2009-11-10
17030SUPPL2009-10-06
17029SUPPL2008-06-30
6981SUPPL2008-06-30
29335ORIG2008-01-30
17028ORIG2008-01-30
53313ORIG1900-01-01
53312ORIG1900-01-01