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 43.

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DIHYDROCHLORIDE2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2008-01-28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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N022157-001XYZAL2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2008-01-2884e616aacf4f…
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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2008-01-28caaa826d4ba7…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UTC2026-02N022157-001XYZAL2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2008-01-28011fe1cb6892…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of this ZIP2025-12N022157-001XYZAL2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2008-01-2831067a03dcf5…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UTC2025-08N022157-001XYZAL2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2008-01-286a471c1ec25d…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…

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 2 of 4 · 75 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDETarget Corporation7e933c85-96b0-b103-e26a-1aa8a1ded58e2026-01-19WarningsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEHEBb13ab6fc-4fec-c870-2c5f-b5e31dec722a2026-01-19WarningsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEDr. Reddy's Laboratories Inc.fb0a3619-9d5b-5c58-82f3-31f031672f332026-01-19WarningsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEWalmart Inc.82da5fa1-3633-2c48-32b9-d15482f308a12026-01-19WarningsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDENorthwind Health Company, LLCf2b458d6-ac10-0fed-e053-2a95a90a0f9c2026-01-01Warnings, Adverse reactionsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDENorthwind Health Company, LLCdae403cd-b6fc-7c50-e053-2995a90a95e32026-01-01Warnings, Adverse reactionsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDERite Aid Corporationfafc8149-d59a-1253-ae79-f33a088e37692025-12-10WarningsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEBJWC (Berkley & Jensen / BJ'S)0216f644-767c-ae88-f48f-cd29ac1547ed2025-12-10WarningsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEChain Drug Marketing Association INC61fb8bef-d868-adee-3237-d3268d603ba62025-12-10WarningsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Allergy ReliefLEVOCETIRIZINE DIHYDROCHLORIDEAMERISOURCEBERGEN DRUG CORPORATIONfdf54de3-16a9-3b28-b4c4-d745322b3d3c2025-12-10WarningsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEUnited Natural Foods, Inc. dba UNFI5036170d-7eeb-65a8-8473-7d98aeb51ee42025-12-10WarningsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEScieGen Pharmaceuticals, Inc.bd7fe481-dfe7-4dfd-aa05-6e2318a9234e2025-10-16Warnings, Adverse reactionsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDECamber Pharmaceuticals, Inc.dd407f8f-140d-489f-b8c5-f6602d87e2472025-10-10Warnings, Adverse reactionsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
allergy reliefLEVOCETIRIZINE DIHYDROCHLORIDERite Aid Corporationc6f826a4-cb8d-4a9f-99cc-5041f65801ca2025-10-09WarningsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEWestminster Pharmaceuticals, LLC85dcd6c0-7fb2-40b3-b07f-93bab169011d2025-09-30Warnings, Adverse reactionsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEBryant Ranch Prepackb7bbffcb-5f56-4735-998a-eadd07dfa2cb2025-09-17Warnings, Adverse reactionsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDEBryant Ranch Prepack1b593c65-2866-45d9-9c94-ac181f4cbc512025-09-15Warnings, Adverse reactionsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.344ba2d6-4e17-4cef-bd7b-248fbb1af3b62025-09-15Warnings, Adverse reactionsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDEMacleods Pharmaceuticals Limited8a3c06a5-4a9a-4205-8ae7-c58efeb73c582025-08-22Warnings, Adverse reactionsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDETeva Pharmaceuticals USA, Inc.4f43d057-cba8-4366-86ba-4be361e4c71f2025-08-11Warnings, Adverse reactionsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE

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
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