Application 209089

Type: NDA
Sponsor: SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XYZAL ALLERGY 24HR	LEVOCETIRIZINE DIHYDROCHLORIDE	TABLET;ORAL	5MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N209089-001	XYZAL ALLERGY 24HR	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL		RLD, RS	2017-01-31

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209089-001	XYZAL ALLERGY 24HR	5MG	TABLET / ORAL	RLD, RS	2017-01-31	`cb3db0bc1861…`

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 Allergy 24HR	LEVOCETIRIZINE DIHYDROCHLORIDE	Chattem, Inc.	8be45c2a-1eca-4a00-81b9-f7babdbdcd41	2026-03-11	Warnings	Exact identifier application applno (NDA): 209089 application number: NDA209089 ndc (product): 41167-3510

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
41167-3510	Xyzal Allergy 24HR	Levocetirizine dihydrochloride	Chattem, Inc.	NDA	Current
41167-3510	Xyzal Allergy 24HR	Levocetirizine dihydrochloride	Chattem, Inc.	NDA	Current
41167-3510	Xyzal Allergy 24HR	Levocetirizine dihydrochloride	Chattem, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
86011	SUPPL	2026-05-21
86007	SUPPL	2026-05-21
79065	SUPPL	2024-07-15
79064	SUPPL	2024-07-15
49021	ORIG	2017-07-20
47067	ORIG	2017-01-31
47065	ORIG	2017-01-31