Application 207235

Type: ANDA
Sponsor: APOTEX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	CAPSULE;ORAL	10MG	No	No

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
A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	CAPSULE / ORAL			2016-08-12

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`e64feba35796…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
All Day Allergy Relief	CETIRIZINE HCL	P & L Development, LLC	0fb52421-a327-4747-880f-d2b7608ccd65	2025-11-17	Warnings	Exact identifier application applno (ANDA): 207235 application number: ANDA207235 ndc (product): 59726-741
Allergy Relief	CETIRIZINE HCL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	d1703629-a641-403f-b547-032a75489d09	2025-07-01	Warnings	Exact identifier application applno (ANDA): 207235 application number: ANDA207235 ndc (product): 49035-841
basic care all day allergy	CETIRIZINE HYDROCHLORIDE	Amazon.com Services LLC	c3e987c5-7ca1-4514-aa0a-6668ff2937c5	2022-01-04	Warnings	Exact identifier application applno (ANDA): 207235 application number: ANDA207235 ndc (product): 72288-007
CareOne Allergy Relief	CETIRIZINE HYDROCHLORIDE	American Sales Company	833e8904-d37d-4478-af7c-8287f2d079a7	2021-08-16	Warnings	Exact identifier application applno (ANDA): 207235 application number: ANDA207235 ndc (product): 41520-715
dg health all day allergy	CETIRIZINE HYDROCHLORIDE	Dolgencorp, LLC	ba7d3995-c992-457c-a628-f036d77cc638	2021-06-01	Warnings	Exact identifier application applno (ANDA): 207235 application number: ANDA207235 ndc (product): 55910-710
top care all day allergy	CETIRIZINE HYDROCHLORIDE	Topco Associates LLC	1a217b8a-621a-4b6d-a7ed-37b04f829d66	2020-06-08	Warnings	Exact identifier application applno (ANDA): 207235 application number: ANDA207235 ndc (product): 36800-180
24 hour allergy	CETIRIZINE HYDROCHLORIDE	Meijer Distribution Inc	e64db82c-6632-421e-8212-e0879445c4d6	2020-06-04	Warnings	Exact identifier application applno (ANDA): 207235 application number: ANDA207235 ndc (product): 41250-618

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 74 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-1036	good sense all day allergy	Cetirizine hydrochloride	L. Perrigo Company	ANDA	Current
0113-7036	BASIC CARE ALL DAY ALLERGY	Cetirizine hydrochloride	L. Perrigo Company	ANDA	Current
0363-0741	Wal-Zyr	Cetirizine HCl	Walgreens	ANDA	Current
0363-0741	Wal-Zyr	Cetirizine HCl	Walgreens	ANDA	Current
0363-0741	Wal-Zyr	Cetirizine HCl	Walgreens	ANDA	Current
0363-1040	Cetirizine	Cetirizine	Walgreens	ANDA	Current
0363-1040	Cetirizine	Cetirizine	Walgreens	ANDA	Current
0363-1040	Cetirizine	Cetirizine	Walgreens	ANDA	Current
11673-219	Cetirizine	Cetirizine	TARGET CORPORATION	ANDA	Current
11673-219	Cetirizine	Cetirizine	TARGET CORPORATION	ANDA	Current
11822-0457	allergy relief	Cetirizine hydrochloride	Rite Aid Corporation	ANDA	Current
21130-741	Allergy Relief	Cetirizine HCl	Safeway, Inc.	ANDA	Current
21130-741	Allergy Relief	Cetirizine HCl	Safeway, Inc.	ANDA	Current
21130-741	Allergy Relief	Cetirizine HCl	Safeway, Inc.	ANDA	Current
30142-741	All Day Allergy Relief	Cetirizine HCl	The Kroger Co.	ANDA	Current
30142-741	All Day Allergy Relief	Cetirizine HCl	The Kroger Co.	ANDA	Current
30142-741	All Day Allergy Relief	Cetirizine HCl	The Kroger Co.	ANDA	Current
33992-0741	Allergy Relief	Cetirizine HCl	ASSURED / DOLLAR TREE (Greenbrier International, Inc.)	ANDA	Current
33992-0741	Allergy Relief	Cetirizine HCl	ASSURED / DOLLAR TREE (Greenbrier International, Inc.)	ANDA	Current
33992-0741	Allergy Relief	Cetirizine HCl	ASSURED / DOLLAR TREE (Greenbrier International, Inc.)	ANDA	Current
33992-0741	Allergy Relief	Cetirizine HCl	ASSURED / DOLLAR TREE (Greenbrier International, Inc.)	ANDA	Current
33992-0741	Allergy Relief	Cetirizine HCl	ASSURED / DOLLAR TREE (Greenbrier International, Inc.)	ANDA	Current
33992-0741	Allergy Relief	Cetirizine HCl	ASSURED / DOLLAR TREE (Greenbrier International, Inc.)	ANDA	Current
36800-180	top care all day allergy	cetirizine hydrochloride	Topco Associates LLC	ANDA	Current
36800-741	All Day Allergy	Cetirizine HCl	TOP CARE (Topco Associates LLC)	ANDA	Current
36800-741	All Day Allergy	Cetirizine HCl	TOP CARE (Topco Associates LLC)	ANDA	Current
36800-741	All Day Allergy	Cetirizine HCl	TOP CARE (Topco Associates LLC)	ANDA	Current
37808-741	Allergy Relief	Cetirizine HCl	H E B	ANDA	Current
37808-741	Allergy Relief	Cetirizine HCl	H E B	ANDA	Current
37808-741	Allergy Relief	Cetirizine HCl	H E B	ANDA	Current
37808-741	Allergy Relief	Cetirizine HCl	H E B	ANDA	Current
41250-618	24 hour allergy	Cetirizine hydrochloride	Meijer Distribution Inc	ANDA	Current
41250-741	Allergy Relief	Cetirizine HCl	MEIJER, INC.	ANDA	Current
41250-741	Allergy Relief	Cetirizine HCl	MEIJER, INC.	ANDA	Current
41250-741	Allergy Relief	Cetirizine HCl	MEIJER, INC.	ANDA	Current
41250-741	Allergy Relief	Cetirizine HCl	MEIJER, INC.	ANDA	Current
41520-715	CareOne Allergy Relief	cetirizine hydrochloride	American Sales Company	ANDA	Current
41520-741	Allergy Relief	Cetirizine HCl	Care One (American Sales Company)	ANDA	Current
41520-741	Allergy Relief	Cetirizine HCl	Care One (American Sales Company)	ANDA	Current
41520-741	Allergy Relief	Cetirizine HCl	Care One (American Sales Company)	ANDA	Current
49035-841	Allergy Relief	Cetirizine HCl	EQUATE (Wal-Mart Stores, Inc.)	ANDA	Current
49035-841	Allergy Relief	Cetirizine HCl	EQUATE (Wal-Mart Stores, Inc.)	ANDA	Current
49035-841	Allergy Relief	Cetirizine HCl	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	ANDA	Current
55315-741	Allergy Relief	Cetirizine HCl	Freds Inc	ANDA	Current
55315-741	Allergy Relief	Cetirizine HCl	Freds Inc	ANDA	Current
55315-741	Allergy Relief	Cetirizine HCl	Freds Inc	ANDA	Current
55315-741	Allergy Relief	Cetirizine HCl	Freds Inc	ANDA	Current
55910-710	dg health all day allergy	Cetirizine hydrochloride	Dolgencorp, LLC	ANDA	Current
56062-741	Allergy Relief	Cetirizine HCl	Publix Supermarkets, Inc.	ANDA	Current
56062-741	Allergy Relief	Cetirizine HCl	Publix Supermarkets, Inc.	ANDA	Current
56062-741	Allergy Relief	Cetirizine HCl	Publix Supermarkets, Inc.	ANDA	Current
59726-041	All Day Allergy Relief	Cetirizine HCl	P & L Development, LLC	ANDA	Current
59726-041	All Day Allergy Relief	Cetirizine HCl	P & L Development, LLC	ANDA	Current
59726-741	All Day Allergy Relief	Cetirizine HCl	P & L Development, LLC	ANDA	Current
59726-741	All Day Allergy Relief	Cetirizine HCl	P & L Development, LLC	ANDA	Current
60505-4322	Cetirizine	Cetirizine	Apotex Corp.	ANDA	Current
60505-4322	Cetirizine	Cetirizine	Apotex Corp.	ANDA	Current
60505-4668	Cetirizine	Cetirizine	Apotex Corp.	ANDA	Current
60505-4668	Cetirizine	Cetirizine	Apotex Corp.	ANDA	Current
60505-4668	Cetirizine	Cetirizine	Apotex Corp.	ANDA	Current
60505-4706	Cetirizine	Cetirizine	Apotex Corp.	ANDA	Current
60505-4706	Cetirizine	Cetirizine	Apotex Corp.	ANDA	Current
60505-4706	Cetirizine	Cetirizine	Apotex Corp.	ANDA	Current
63868-432	All Day Allergy Relief	Cetirizine HCl	QUALITY CHOICE (Chain Drug Marketing Association)	ANDA	Current
63868-432	All Day Allergy Relief	Cetirizine HCl	QUALITY CHOICE (Chain Drug Marketing Association)	ANDA	Current
63868-432	All Day Allergy Relief	Cetirizine HCl	QUALITY CHOICE (Chain Drug Marketing Association)	ANDA	Current
69230-303	Allergy Relief	Cetirizine HCl	Camber Consumer Care	ANDA	Current
69230-303	Allergy Relief	Cetirizine HCl	Camber Consumer Care	ANDA	Current
69230-303	Allergy Relief	Cetirizine HCl	Camber Consumer Care	ANDA	Current
69230-303	Allergy Relief	Cetirizine HCl	Camber Consumer Care	ANDA	Current
69842-741	Allergy Relief	Cetirizine HCl	CVS Pharmacy	ANDA	Current
69842-741	Allergy Relief	Cetirizine HCl	CVS Pharmacy	ANDA	Current
69842-741	Allergy Relief	Cetirizine HCl	CVS Pharmacy	ANDA	Current
72288-007	basic care all day allergy	Cetirizine hydrochloride	Amazon.com Services LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
45224	ORIG	2016-08-12