Application 022157

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	SOLUTION;ORAL	2.5MG/5ML	Yes	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022157-001	XYZAL	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2008-01-28

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022157-001	XYZAL	2.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2008-01-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022157-001	XYZAL	2.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2008-01-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022157-001	XYZAL	2.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2008-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022157-001	XYZAL	2.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2008-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022157-001	XYZAL	2.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2008-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022157-001	XYZAL	2.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2008-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022157-001	XYZAL	2.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2008-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022157-001	XYZAL	2.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2008-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022157-001	XYZAL	2.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2008-01-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022157-001	XYZAL	2.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2008-01-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022157-001	XYZAL	2.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2008-01-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022157-001	XYZAL	2.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2008-01-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022157-001	XYZAL	2.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2008-01-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022157-001	XYZAL	2.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2008-01-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022157-001	XYZAL	2.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2008-01-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022157-001	XYZAL	2.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2008-01-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022157-001	XYZAL	2.5MG/5ML	SOLUTION / ORAL		RLD	2008-01-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022157-001	XYZAL	2.5MG/5ML	SOLUTION / ORAL		RLD	2008-01-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022157-001	XYZAL	2.5MG/5ML	SOLUTION / ORAL		RLD	2008-01-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022157-001	XYZAL	2.5MG/5ML	SOLUTION / ORAL	AA	RLD	2008-01-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022157-001	XYZAL	2.5MG/5ML	SOLUTION / ORAL		RLD	2008-01-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022157-001	XYZAL	2.5MG/5ML	SOLUTION / ORAL		RLD	2008-01-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022157-001	XYZAL	2.5MG/5ML	SOLUTION / ORAL	AA	RLD	2008-01-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022157-001	XYZAL	2.5MG/5ML	SOLUTION / ORAL	AA	RLD	2008-01-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022157-001	XYZAL	2.5MG/5ML	SOLUTION / ORAL	AA	RLD	2008-01-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022157-001	XYZAL	2.5MG/5ML	SOLUTION / ORAL	AA	RLD	2008-01-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022157-001	XYZAL	2.5MG/5ML	SOLUTION / ORAL	AA	RLD	2008-01-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022157-001	XYZAL	2.5MG/5ML	SOLUTION / ORAL	AA	RLD	2008-01-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022157-001	XYZAL	2.5MG/5ML	SOLUTION / ORAL	AA	RLD	2008-01-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022157-001	XYZAL	2.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2008-01-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022157-001	XYZAL	2.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2008-01-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022157-001	XYZAL	2.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2008-01-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022157-001	XYZAL	2.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2008-01-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022157-001	XYZAL	2.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2008-01-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022157-001	XYZAL	2.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2008-01-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022157-001	XYZAL	2.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2008-01-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022157-001	XYZAL	2.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2008-01-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022157-001	XYZAL	2.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2008-01-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022157-001	XYZAL	2.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2008-01-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022157-001	XYZAL	2.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2008-01-28	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022157-001	AA	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022157-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022157-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022157-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022157-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022157-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022157-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022157-001	AA	1	`ea99ee380514…`

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 3 of 4 · 75 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Micro Labs Limited	717eb542-3a05-485e-be76-3930efb40d33	2025-08-01	Warnings, Adverse reactions	Name fallback generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Padagis Israel Pharmaceuticals Ltd	2965ef46-18db-4615-9dce-bfb0f0b3366a	2025-07-31	Warnings, Adverse reactions	Name fallback generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Xyzal	LEVOCETIRIZINE DIHYDROCHLORIDE	Chattem, Inc.	1673f7ff-0c7c-4403-86cf-c05eb1475222	2025-07-22	Warnings, Adverse reactions	Name fallback brand name: Xyzal generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
allergy relief	LEVOCETIRIZINE DIHYDROCHLORIDE	Walgreen Company	5033f8e3-c1c4-44e9-a774-703d9b04e82c	2025-07-16	Warnings	Name fallback generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	8f308352-5854-409e-8bf7-bc9958cc3c5e	2025-07-14	Warnings, Adverse reactions	Name fallback generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Proficient Rx LP	9f83891c-2466-4972-b0f4-b92cc7337be3	2025-07-01	Warnings, Adverse reactions	Name fallback generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Bryant Ranch Prepack	e885f084-9ce2-4e0c-aadb-c9d651224e5b	2025-06-27	Warnings, Adverse reactions	Name fallback generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Camber Pharmaceuticals, Inc.	dc8adb01-a7ca-490b-b476-8915f1a2e6db	2025-06-12	Warnings, Adverse reactions	Name fallback generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Allergy Relief	LEVOCETIRIZINE DIHYDROCHLORIDE	Meijer Distribution Inc	ca6d0ba0-96af-41e9-a3e9-0c7783db3011	2025-05-20	Warnings	Name fallback generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	348eadb6-5be2-f8c7-e063-6394a90a1314	2025-05-07	Warnings, Adverse reactions	Name fallback generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	Proficient Rx LP	fe13f6c0-610b-43b6-8693-e9923ba405d5	2025-03-01	Warnings, Adverse reactions	Name fallback generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	51d88b2a-d10d-4e7a-b874-98de48069223	2025-02-21	Warnings, Adverse reactions	Name fallback generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Micro Labs Limited	78ff8e86-ee5b-4626-aa81-49e974febf1d	2025-02-16	Warnings	Name fallback generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	57c7c673-790c-4158-87ca-7d8fb68c4286	2025-02-04	Warnings, Adverse reactions	Name fallback generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	Preferred Pharmaceuticals Inc.	5d6941c7-ef0a-48d3-93dc-53bc2c9789de	2025-01-20	Warnings, Adverse reactions	Name fallback generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	2787aaa2-5209-f7d5-e063-6294a90a7103	2024-11-22	Warnings, Adverse reactions	Name fallback generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Allergy Relief 24HR	LEVOCETIRIZINE DIHYDROCHLORIDE	VELOCITY PHARMA LLC	8ba208dc-34fe-453a-8658-ed4f232e1a94	2024-10-29	Warnings	Name fallback generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Bryant Ranch Prepack	628c26f0-f6bb-4658-ba50-8ca04cd859cb	2024-07-10	Warnings, Adverse reactions	Name fallback generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	97a67686-7e94-dd77-e053-2995a90a42c6	2024-06-19	Warnings, Adverse reactions	Name fallback generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Bryant Ranch Prepack	4d0a0f8e-b298-46d2-b27d-0bb737507fed	2024-04-12	Warnings, Adverse reactions	Name 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
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0024-5804	Xyzal	levocetirizine dihydrochloride	Sanofi-Aventis U.S. LLC	NDA	Current
0024-5804	Xyzal	levocetirizine dihydrochloride	Sanofi-Aventis U.S. LLC	NDA	Current
0024-5804	Xyzal	levocetirizine dihydrochloride	Sanofi-Aventis U.S. LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82833	SUPPL	2025-07-14
82829	SUPPL	2025-07-14
58215	SUPPL	2019-04-04
58196	SUPPL	2019-04-03
57255	SUPPL	2019-01-18
57233	SUPPL	2019-01-16
53594	SUPPL	2018-04-03
53593	SUPPL	2018-04-03
50109	SUPPL	2017-10-19
50064	SUPPL	2017-10-17
48969	SUPPL	2017-07-13
48964	SUPPL	2017-07-13
47235	SUPPL	2017-02-16
47167	SUPPL	2017-02-10
45860	SUPPL	2016-11-09
45857	SUPPL	2016-11-09
17033	SUPPL	2016-06-27
29337	SUPPL	2016-06-24
17032	SUPPL	2013-11-08
6984	SUPPL	2013-11-08
38317	SUPPL	2012-09-11
29336	SUPPL	2012-09-07
6983	SUPPL	2011-03-10
17031	SUPPL	2011-03-07
44687	ORIG	2010-04-01
42433	ORIG	2010-04-01
6982	SUPPL	2009-11-10
17030	SUPPL	2009-10-06
17029	SUPPL	2008-06-30
6981	SUPPL	2008-06-30
29335	ORIG	2008-01-30
17028	ORIG	2008-01-30
53313	ORIG	1900-01-01
53312	ORIG	1900-01-01