Application 209090

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	SOLUTION;ORAL	2.5MG/5ML	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
N209090-001	XYZAL ALLERGY 24HR	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL		RLD, RS	2017-01-31

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209090-001	8633194	2027-10-16		Drug product	2017-02-28

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 · 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	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`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
Childrens Xyzal Allergy	LEVOCETIRIZINE DIHYDROCHLORIDE	Chattem, Inc.	a33f2704-d350-428b-b467-91f4775ce17f	2026-02-05	Warnings	Exact identifier application applno (NDA): 209090 application number: NDA209090 ndc (product): 41167-3530

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
41167-3530	Childrens Xyzal Allergy	Levocetirizine dihydrochloride	Chattem, Inc.	NDA	Current
41167-3530	Childrens Xyzal Allergy	Levocetirizine dihydrochloride	Chattem, Inc.	NDA	Current
41167-3530	Childrens Xyzal Allergy	Levocetirizine dihydrochloride	Chattem, Inc.	NDA	Current
41167-3530	Childrens Xyzal Allergy	Levocetirizine dihydrochloride	Chattem, Inc.	NDA	Current
41167-3530	Childrens Xyzal Allergy	Levocetirizine dihydrochloride	Chattem, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85290	SUPPL	2026-03-09
82910	SUPPL	2025-07-23
82909	SUPPL	2025-07-23
72505	SUPPL	2022-10-31
72502	SUPPL	2022-10-31
71553	SUPPL	2022-07-14
71551	SUPPL	2022-07-14
67016	SUPPL	2021-04-09
65199	SUPPL	2020-11-12
49022	ORIG	2017-07-20
47068	ORIG	2017-01-31
47066	ORIG	2017-01-31