Application 022429

Type: NDA
Sponsor: BIONPHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	CAPSULE;ORAL	5MG	Yes	No
002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	CAPSULE;ORAL	10MG	Yes	Yes
003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	CAPSULE;ORAL	5MG	Yes	No
004	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	CAPSULE;ORAL	10MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	RLD	2009-07-23
N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23
N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	RLD	2009-07-23
N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23

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 5 · 164 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	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`d06236e962d9…`

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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	CETIRIZINE HCL	Whole Foods Market, INC.	453b20b5-72a7-ac09-e063-6394a90afc4b	2026-06-22	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	PUBLIX SUPER MARKETS INC	4d652305-67f3-33f3-e063-6294a90a367e	2026-06-22	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	AMERISOURCE BERGEN	518ed897-7365-0520-e063-6394a90a06d6	2026-05-11	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	TOP CARE (Topco Associates LLC)	3363bd32-cac6-e10c-e063-6294a90a2638	2026-05-11	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	Meijer Distribution Inc	3143de16-2006-ec2e-e063-6294a90a1f67	2026-04-20	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	WALGREEN COMPANY	4a181a38-ac94-8d00-e063-6394a90a6bf6	2026-04-20	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	Bionpharma Inc.	4fe8f764-a8e2-a432-e063-6294a90a33b0	2026-04-20	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	TARGET Corporation	363845a9-c379-16a7-e063-6394a90a011a	2026-04-20	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	KROGER COMPANY	33f181f8-6e0d-b89b-e063-6394a90aeae7	2026-04-20	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	Bionpharma Inc.	2c2c4828-0479-4ff3-b2b0-dde5fa74efaf	2025-12-16	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429 ndc (product): 69452-265
Cetirizine HCl	CETIRIZINE HCL	TARGET Corporation	e39a1a4f-c786-479a-9c11-aaf591810fe7	2025-12-16	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429 ndc (product): 11673-242
Cetirizine HCl	CETIRIZINE HCL	KROGER COMPANY	63ddeea4-d701-42b2-bcb7-81c0e43eb013	2025-11-24	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429 ndc (product): 30142-995
Cetirizine HCl	CETIRIZINE HCL	Meijer Distribution Inc	235bf16e-4c23-95f8-e063-6394a90a62d5	2024-11-25	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	DOLGENCORP INC	235c2640-8d6a-249d-e063-6394a90a132a	2024-11-25	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	TOP CARE (Topco Associates LLC)	2033e2c3-81af-b1cf-e063-6394a90adbc5	2024-11-22	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	PUBLIX SUPER MARKETS INC	1ab5c526-b5fd-fca0-e063-6294a90ac54a	2024-10-03	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
24 HOUR ALLERGY	CETIRIZINE HCL	Walgreens	f3168f2c-27a7-4dd7-9770-e91443a580f1	2024-04-01	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429 ndc (product): 0363-1219
Cetirizine HCl	CETIRIZINE HCL	Northeast Pharma	0647ef4c-8912-9f44-e063-6294a90ae3a6	2023-09-26	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
All Day Allergy Relief	CETIRIZINE HCL	CHAIN DRUG MARKETING ASSOCIATION INC.	ec81dc4c-74c0-4719-be5d-686d545f4003	2022-12-29	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429 ndc (product): 63868-433
Allergy Relief	CETIRIZINE HCL	DISCOUNT DRUG MART, INC.	89c77f0d-a325-4f8f-9142-98c0d41de8b1	2022-12-29	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429 ndc (product): 53943-219

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 76 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-0211	24 Hour Allergy	Cetirizine HCl	Walgreens	NDA	Current
0363-0211	Wal-Zyr	Cetirizine HCl	Walgreens	NDA	Current
0363-0921	Wal-Zyr	Cetirizine HCl	Walgreens	NDA	Current
0363-0921	Allergy Relief	Cetirizine HCl	Walgreens	NDA	Current
0363-0921	Wal-Zyr	Cetirizine HCl	Walgreens	NDA	Current
0363-0921	Wal-Zyr	Cetirizine HCl	Walgreens	NDA	Current
0363-1219	24 Hour Allergy	Cetirizine HCl	Walgreens	NDA	Current
0363-1219	24 HOUR ALLERGY	Cetirizine HCl	Walgreens	NDA	Current
0363-1219	24 HOUR ALLERGY	Cetirizine HCl	Walgreens	NDA	Current
0363-1219	24 Hour Allergy	Cetirizine HCl	Walgreens	NDA	Current
11673-211	Allergy Relief	Cetirizine HCl	TARGET Corporation	NDA	Current
11673-211	Allergy Relief	Cetirizine HCl	TARGET Corporation	NDA	Current
11673-242	Cetirizine HCl	Cetirizine HCl	TARGET Corporation	NDA	Current
11673-242	Cetirizine HCl	Cetirizine HCl	TARGET Corporation	NDA	Current
30142-211	All Day Allergy	Cetirizine HCl	The Kroger Co.	NDA	Current
30142-211	All Day Allergy	Cetirizine HCl	The Kroger Co.	NDA	Current
30142-211	All Day Allergy	Cetirizine HCl	The Kroger Co.	NDA	Current
30142-995	Cetirizine HCl	Cetirizine HCl	KROGER COMPANY	NDA	Current
30142-995	Cetirizine HCl	Cetirizine HCl	KROGER COMPANY	NDA	Current
30142-995	Cetirizine HCl	Cetirizine HCl	KROGER COMPANY	NDA	Current
36800-211	All Day Allergy	Cetirizine HCl	TOP CARE (Topco Associates LLC)	NDA	Current
36800-211	All Day Allergy	Cetirizine HCl	TOP CARE (Topco Associates LLC)	NDA	Current
37205-819	All Day Allergy	Cetirizine HCl	Cardinal Health (Leader) 37205	NDA	Current
37808-211	All Day Allergy	Cetirizine HCl	H E B	NDA	Current
37808-211	All Day Allergy	Cetirizine HCl	H E B	NDA	Current
37808-211	All Day Allergy	Cetirizine HCl	H E B	NDA	Current
41163-219	all day allergy	Cetirizine HCl	SUPERVALU INC	NDA	Current
41520-211	All Day Allergy	Cetirizine HCl	Care One (American Sales Company)	NDA	Current
41520-211	All Day Allergy	Cetirizine HCl	Care One (American Sales Company)	NDA	Current
42507-211	All Day Allergy	Cetirizine HCl	Hy-Vee	NDA	Current
42507-211	All Day Allergy	Cetirizine HCl	Hy-Vee	NDA	Current
42507-211	All Day Allergy	Cetirizine HCl	Hy-Vee	NDA	Current
46122-613	Cetirizine HCl	Cetirizine HCl	AMERISOURCE BERGEN	NDA	Current
46122-613	Cetirizine HCl	Cetirizine HCl	AMERISOURCE BERGEN	NDA	Current
49035-711	Allergy Relief	Cetirizine HCl	EQUATE (Wal-Mart Stores, Inc.)	NDA	Current
49035-711	Allergy Relief	Cetirizine HCl	EQUATE (Wal-Mart Stores, Inc.)	NDA	Current
49035-711	Allergy Relief	Cetirizine HCl	EQUATE (Wal-Mart Stores, Inc.)	NDA	Current
49035-911	Allergy Relief	Cetirizine HCl	EQUATE (Wal-Mart Stores, Inc.)	NDA	Current
49035-911	Allergy Relief	Cetirizine HCl	EQUATE (Wal-Mart Stores, Inc.)	NDA	Current
49035-911	Allergy Relief	Cetirizine HCl	EQUATE (Wal-Mart Stores, Inc.)	NDA	Current
49738-211	Cetirizine HCl	Cetirizine Hydrochloride	SMART SENSE (Kmart)	NDA	Current
49738-211	Cetirizine HCl	Cetirizine Hydrochloride	SMART SENSE (Kmart)	NDA	Current
49738-211	Cetirizine HCl	Cetirizine Hydrochloride	SMART SENSE (Kmart)	NDA	Current
50580-779	ZYRTEC	Cetirizine Hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-779	ZYRTEC	Cetirizine Hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-779	ZYRTEC	Cetirizine Hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
53943-219	Allergy Relief	Cetirizine HCl	DISCOUNT DRUG MART, INC.	NDA	Current
53943-219	Allergy Relief	Cetirizine HCl	DISCOUNT DRUG MART, INC.	NDA	Current
55312-211	Allergy Relief	Cetirizine HCl	Western Family Foods, Inc.	NDA	Current
55315-211	All Day Allergy	Cetirizine HCl	Freds Inc	NDA	Current
55315-211	All Day Allergy	Cetirizine HCl	Freds Inc	NDA	Current
56062-211	Allergy Relief	Cetirizine HCl	Publix Supermarkets, Inc.	NDA	Current
56062-211	Allergy Relief	Cetirizine HCl	Publix Supermarkets, Inc.	NDA	Current
56062-211	Allergy Relief	Cetirizine HCl	Publix Supermarkets, Inc.	NDA	Current
59726-211	All Day Allergy	Cetirizine HCl	P & L Development, LLC	NDA	Current
59726-212	All Day Allergy Relief	Cetirizine HCl	P & L Development, LLC	NDA	Current
59726-212	All Day Allergy Relief	Cetirizine HCl	P & L Development, LLC	NDA	Current
59726-212	All Day Allergy Relief	Cetirizine HCl	P & L Development, LLC	NDA	Current
59779-415	Indoor/Outdoor ALLERGY RELIEF Softgels	Cetirizine Hydrochloride	CVS Pharmacy	NDA	Current
63868-107	All Day Allergy Relief	Cetirizine HCl	QUALITY CHOICE (Chain Drug Marketing Association)	NDA	Current
63868-139	All Day Allergy	Cetirizine HCl	QUALITY CHOICE (Chain Drug Marketing Association)	NDA	Current
63868-139	All Day Allergy	Cetirizine HCl	QUALITY CHOICE (Chain Drug Marketing Association)	NDA	Current
63868-139	All Day Allergy	Cetirizine HCl	QUALITY CHOICE (Chain Drug Marketing Association)	NDA	Current
63868-433	All Day Allergy Relief	Cetirizine HCl	CHAIN DRUG MARKETING ASSOCIATION INC.	NDA	Current
63868-433	All Day Allergy Relief	Cetirizine HCl	CHAIN DRUG MARKETING ASSOCIATION INC.	NDA	Current
63868-433	All Day Allergy Relief	Cetirizine HCl	CHAIN DRUG MARKETING ASSOCIATION INC.	NDA	Current
63940-211	Allergy Relief	Cetirizine HCl	Harmon Stores	NDA	Current
63940-211	Allergy Relief	Cetirizine HCl	Harmon Stores	NDA	Current
68016-279	All Day Allergy	Cetirizine Hydrochloride	Chain Drug Consortium, LLC	NDA	Current
69452-265	Cetirizine HCl	Cetirizine HCl	Bionpharma Inc.	NDA	Current
69452-265	Cetirizine HCl	Cetirizine HCl	Bionpharma Inc.	NDA	Current
69452-265	Cetirizine HCl	Cetirizine HCl	Bionpharma Inc.	NDA	Current
69452-265	Cetirizine HCl	Cetirizine HCl	Bionpharma Inc.	NDA	Current
69842-911	ALLERGY RELIEF	Cetirizine Hydrochloride	CVS Pharmacy	NDA	Current
69842-911	ALLERGY RELIEF	Cetirizine Hydrochloride	CVS Pharmacy	NDA	Current
69842-911	ALLERGY RELIEF	Cetirizine Hydrochloride	CVS Pharmacy	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84917	SUPPL	2026-02-05
84893	SUPPL	2026-02-03
65538	SUPPL	2020-12-09
62568	SUPPL	2020-04-14
62567	SUPPL	2020-04-14
17582	SUPPL	2014-01-14
29725	SUPPL	2013-02-07
7385	SUPPL	2010-04-08
42521	ORIG	2009-12-16