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 42.

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XYZAL	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2007-05-25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 1 of 2 · 42 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
2026-08-18 06:07:40	2026-07	N022064-001	XYZAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2007-05-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022064-001	XYZAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2007-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022064-001	XYZAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2007-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022064-001	XYZAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2007-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022064-001	XYZAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2007-05-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	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	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	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	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	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	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	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	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	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	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	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	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	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	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	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	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	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	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	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	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022064-001	XYZAL	5MG	TABLET / ORAL		RLD	2007-05-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022064-001	XYZAL	5MG	TABLET / ORAL		RLD	2007-05-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022064-001	XYZAL	5MG	TABLET / ORAL		RLD	2007-05-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022064-001	XYZAL	5MG	TABLET / ORAL	AB	RLD, RS	2007-05-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022064-001	XYZAL	5MG	TABLET / ORAL		RLD	2007-05-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022064-001	XYZAL	5MG	TABLET / ORAL		RLD	2007-05-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022064-001	XYZAL	5MG	TABLET / ORAL	AB	RLD, RS	2007-05-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022064-001	XYZAL	5MG	TABLET / ORAL	AB	RLD, RS	2007-05-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022064-001	XYZAL	5MG	TABLET / ORAL	AB	RLD, RS	2007-05-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022064-001	XYZAL	5MG	TABLET / ORAL	AB	RLD, RS	2007-05-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022064-001	XYZAL	5MG	TABLET / ORAL	AB	RLD, RS	2007-05-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022064-001	XYZAL	5MG	TABLET / ORAL	AB	RLD, RS	2007-05-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022064-001	XYZAL	5MG	TABLET / ORAL	AB	RLD, RS	2007-05-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	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	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	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	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`
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…`

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	N022064-001	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022064-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022064-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022064-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022064-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022064-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022064-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022064-001	AB	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 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

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82832	SUPPL	2025-07-14
82828	SUPPL	2025-07-14
58214	SUPPL	2019-04-04
58195	SUPPL	2019-04-03
57254	SUPPL	2019-01-18
57232	SUPPL	2019-01-16
53596	SUPPL	2018-04-03
53595	SUPPL	2018-04-03
50116	SUPPL	2017-10-19
50065	SUPPL	2017-10-17
48970	SUPPL	2017-07-13
48963	SUPPL	2017-07-13
47234	SUPPL	2017-02-16
47166	SUPPL	2017-02-10
45859	SUPPL	2016-11-09
45856	SUPPL	2016-11-09
38173	SUPPL	2016-06-27
29183	SUPPL	2016-06-24
38172	SUPPL	2013-11-08
6801	SUPPL	2013-11-08
38171	SUPPL	2012-09-11
6800	SUPPL	2012-09-07
6799	SUPPL	2011-03-10
16872	SUPPL	2011-03-07
6798	SUPPL	2009-11-10
38170	SUPPL	2009-10-06
52313	ORIG	2009-08-25
44671	ORIG	2008-10-15
42405	ORIG	2008-10-15
16869	ORIG	2008-04-09
6796	ORIG	2008-04-09
29182	SUPPL	2008-04-02
16871	SUPPL	2008-04-01
16870	SUPPL	2008-02-14
6797	SUPPL	2008-02-05
53311	ORIG	1900-01-01
53310	ORIG	1900-01-01