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 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
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 · 41 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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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