Application 201546

Type: ANDA
Sponsor: TARO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	SYRUP;ORAL	5MG/5ML	No	No
002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	SYRUP;ORAL	5MG/5ML	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A201546-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL			2011-05-20
A201546-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL			2011-05-20

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201546-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201546-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-05-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201546-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201546-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-05-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201546-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201546-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201546-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-05-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201546-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-05-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201546-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-05-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201546-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-05-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201546-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-05-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201546-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-05-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201546-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-05-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201546-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-05-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201546-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-05-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201546-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-05-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201546-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-05-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201546-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-05-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201546-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-05-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201546-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-05-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201546-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-05-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201546-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-05-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201546-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-05-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201546-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-05-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201546-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-05-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201546-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-05-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201546-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-05-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201546-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-05-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201546-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2011-05-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201546-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2011-05-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201546-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2011-05-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201546-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2011-05-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201546-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2011-05-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201546-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2011-05-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201546-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2011-05-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201546-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2011-05-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201546-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2011-05-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201546-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2011-05-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201546-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2011-05-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201546-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2011-05-20	`782e0a99824c…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	67207357-5f8a-4424-9901-d2717a43cf1b	2026-07-14	Warnings	Exact identifier application applno (ANDA): 201546 application number: ANDA201546 ndc (product): 51672-2106
Rite Aid childrens allergy relief	CETIRIZINE HYDROCHLORIDE	Rite Aid Corporation	edbefbee-26b6-46bc-abcc-f7b2817705e5	2024-12-19	Warnings	Exact identifier application applno (ANDA): 201546 application number: ANDA201546 ndc (product): 11822-2106
Childrens Allergy	CETIRIZINE HYDROCHLORIDE	Publix Super Markets Inc	9a8b5af0-72bb-48d5-bb5e-0dc6808bf466	2024-12-19	Warnings	Exact identifier application applno (ANDA): 201546 application number: ANDA201546 ndc (product): 56062-106
All Day Allergy	CETIRIZINE HYDROCHLORIDE	Amerisource Bergen	6ce39876-47bf-4147-885d-4eb0aeb66fd0	2020-06-18	Warnings	Exact identifier application applno (ANDA): 201546 application number: ANDA201546 ndc (product): 46122-101
Wal-Zyr All Day Allergy	CETIRIZINE HYDROCHLORIDE	WALGREEN COMPANY	4ce79791-748a-49d0-af34-73f589670d3f	2019-02-07	Warnings	Exact identifier application applno (ANDA): 201546 application number: ANDA201546 ndc (product): 0363-2106
Allergy Relief	CETIRIZINE HYDROCHLORIDE	H E B	fdd3f9a0-b4be-498a-b8e0-1a9740399736	2018-05-09	Warnings	Exact identifier application applno (ANDA): 201546 application number: ANDA201546 ndc (product): 37808-106
Childrens Allergy Relief	CETIRIZINE HYDROCHLORIDE	Wal-Mart Stores Inc	0d026538-5708-4030-b65d-18790e72059a	2018-02-14	Warnings	Exact identifier application applno (ANDA): 201546 application number: ANDA201546 ndc (product): 49035-106
Childrens Cetirzine	CETIRIZINE HYDROCHLORIDE	Pharmacy Value Alliance LLC	6b22f568-7ebd-4479-b764-6e5481d8c15a	2017-06-12	Warnings	Exact identifier application applno (ANDA): 201546 application number: ANDA201546 ndc (product): 68016-106

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-2106	Wal-Zyr	Cetirizine Hydrochloride	WALGREEN COMPANY	ANDA	Current
11673-106	up and up	Cetirizine Hydrochloride	Target Corporation	ANDA	Current
11822-2106	Rite Aid	Cetirizine Hydrochloride	Rite Aid Corporation	ANDA	Current
11822-2106	Rite Aid	Cetirizine Hydrochloride	Rite Aid Corporation	ANDA	Current
11822-2106	Rite Aid	Cetirizine Hydrochloride	Rite Aid Corporation	ANDA	Current
21130-106	Safeway	Cetirizine Hydrochloride	Safeway Inc.	ANDA	Current
30142-106	Childrens	Cetirizine Hydrochloride	Kroger Company	ANDA	Current
37205-591	Leader Childrens Allergy Relief	Cetirizine Hydrochloride	Cardinal Health	ANDA	Current
37808-106	Allergy Relief	Cetirizine Hydrochloride	H E B	ANDA	Current
41250-106	Childrens	Cetirizine Hydrochloride	Meijer Distribution Inc	ANDA	Current
46122-101	All Day	Cetirizine Hydrochloride	Amerisource Bergen	ANDA	Current
46122-101	All Day	Cetirizine Hydrochloride	Amerisource Bergen	ANDA	Current
49035-106	Childrens	Cetirizine Hydrochloride	Wal-Mart Stores Inc	ANDA	Current
49348-078	Childrens	Cetirizine Hydrochloride	McKesson	ANDA	Current
51672-2106	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-2106	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-2148	CHILDRENS CETIRIZINE HYDROCHLORIDE	Cetirizine Hydrochloride	TARO PHARMACEUTICALS U.S.A., INC.	ANDA	Current
52549-2106	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Taro Pharmaceutical Industries, Ltd.	ANDA	Current
55312-106	Western Family	Cetirizine Hydrochloride	Western Family Foods Inc	ANDA	Current
56062-106	Childrens Allergy	Cetirizine Hydrochloride	Publix Super Markets Inc	ANDA	Current
56062-106	Childrens Allergy	Cetirizine Hydrochloride	Publix Super Markets Inc	ANDA	Current
59779-106	CVS	Cetirizine Hydrochloride	CVS Pharmacy	ANDA	Current
62011-0093	Childrens Cetirizine Hydrochloride	Cetirizine hydrochloride	Health Mart	ANDA	Current
63868-106	Quality Choice	Cetirizine Hydrochloride	Chain Drug Marketing Association	ANDA	Current
68016-106	Childrens	Cetirizine Hydrochloride	Pharmacy Value Alliance LLC	ANDA	Current
70253-106	Our Family	Cetirizine Hydrochloride	Nash Finch Company	ANDA	Current