Application 077498

Type: ANDA
Sponsor: SUN PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
002	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
003	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
004	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	TABLET;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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2007-12-27
A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2007-12-27
A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2007-12-27
A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2007-12-27

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 · 168 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	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`d8e5a09893c0…`

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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Sportpharm LLC	357523b6-618b-4bff-a80d-c62e72a0804e	2026-05-08	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	a7da81e1-8865-45c9-83c7-32fb8032ca2e	2026-03-19	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498 ndc (product): 55289-995
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Marlex Pharmaceuticals, Inc	eb917099-fecf-6b55-e053-2995a90aaafa	2025-09-23	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498 ndc (product): 10135-762
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	d0d8b376-9001-8776-e053-2a95a90ae651	2024-08-12	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498 ndc (product): 68071-2571
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	15eaa0d1-d18d-72b1-e063-6394a90a8a94	2024-04-12	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Proficient Rx LP	d14feb90-3ca2-4d5b-825c-25fc2252ca38	2022-06-01	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498 ndc (product): 63187-110
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Ohm Laboratories Inc.	161c4122-2c89-46e6-a6ae-db088087330d	2021-05-21	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498 ndc (product): 51660-939
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Publix Super Markets Inc	a0a063a1-e067-480e-afab-7f01165025f4	2019-08-19	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498 ndc (product): 56062-939
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Chain Drug Consortium, LLC	9d7d2342-a594-4851-810b-b7bce1bd07dc	2018-08-24	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498 ndc (product): 68016-939
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Valu Merchandisers Company	4a8d2887-8ac3-4d54-9e67-4a271d416426	2018-08-23	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498 ndc (product): 63941-939
Quality Choice Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Chain Drug Marketing Association Inc.	2e8cc4e3-8386-42de-801f-fef37f612849	2018-08-22	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498 ndc (product): 63868-132
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Marc Glassman, Inc.	f30900e6-425f-43e0-81b6-1fa3bd321f0b	2018-06-20	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498 ndc (product): 68998-939
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	LIDL US, LLC	a210d6b7-0829-4120-bb6d-fee0c2e57b26	2018-01-09	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498 ndc (product): 71141-133
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	FAMILY DOLLAR SERVICES, INC	b326dacc-6123-47a7-9fde-6909db1d780b	2018-01-08	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498 ndc (product): 55319-939

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 50 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6100	Cetirizine hydrochloride	Cetirizine hydrochloride	Major Pharmaceuticals	ANDA	Current
10135-762	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Marlex Pharmaceuticals, Inc	ANDA	Current
10135-762	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Marlex Pharmaceuticals, Inc	ANDA	Current
10202-939	Cetirizine Hydrochloride	Cetirizine Hydrochloride	7-ELEVEN	ANDA	Current
15127-909	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Select Brand	ANDA	Current
36800-244	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Topco Associates LLC	ANDA	Current
37012-939	Cetirizine Hydrochloride	Cetirizine	Shopko Stores Operating Co., LLC	ANDA	Current
37205-820	LEADER ALL DAY ALLERGY	cetirizine	Cardinal Health	ANDA	Current
42254-138	Cetirizine hydrochloride	Cetirizine hydrochloride	Rebel Distributors Corp	ANDA	Current
49348-389	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Sunmark	ANDA	Current
50090-5518	Cetirizine Hydrochloride	Cetirizine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5518	Cetirizine Hydrochloride	Cetirizine Hydrochloride	A-S Medication Solutions	ANDA	Current
51660-939	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Ohm Laboratories Inc.	ANDA	Current
51660-939	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Ohm Laboratories Inc.	ANDA	Current
51660-939	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Ohm Laboratories Inc.	ANDA	Current
51660-939	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Ohm Laboratories Inc.	ANDA	Current
53329-652	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Medline Industries, Inc.	ANDA	Current
53329-652	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Medline Industries, Inc.	ANDA	Current
53329-652	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Medline Industries, Inc.	ANDA	Current
53329-652	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Medline Industries, Inc.	ANDA	Current
53329-652	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Medline Industries, LP	ANDA	Current
53329-652	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Medline Industries, LP	ANDA	Current
55289-995	Cetirizine Hydrochloride	Cetirizine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-995	Cetirizine Hydrochloride	Cetirizine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-995	Cetirizine Hydrochloride	Cetirizine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-995	Cetirizine Hydrochloride	Cetirizine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-995	Cetirizine Hydrochloride	Cetirizine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-995	Cetirizine Hydrochloride	Cetirizine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-995	Cetirizine Hydrochloride	Cetirizine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-995	Cetirizine Hydrochloride	Cetirizine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55301-939	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Army & Air Force Exchange Service	ANDA	Current
55319-939	Cetirizine Hydrochloride	Cetirizine Hydrochloride	FAMILY DOLLAR SERVICES, INC	ANDA	Current
56062-939	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Publix Super Markets Inc	ANDA	Current
56062-939	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Publix Super Markets Inc	ANDA	Current
57451-5067	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Ipca Laboratories Limited	ANDA	Current
58593-827	Zero Allergy	Cetirizine Hydrochloride	Efficient Laboratories Inc	ANDA	Current
58593-827	Zero Allergy	Cetirizine Hydrochloride	Efficient Laboratories Inc	ANDA	Current
59779-939	Cetirizine Hydrochloride	Cetirizine Hydrochloride	CVS Pharmacy	ANDA	Current
61715-062	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Kinray	ANDA	Current
63187-110	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Proficient Rx LP	ANDA	Current
63187-110	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Proficient Rx LP	ANDA	Current
63187-110	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Proficient Rx LP	ANDA	Current
63187-110	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Proficient Rx LP	ANDA	Current
63868-132	Quality Choice Cetirizine Hydrochloride	Cetirizine Hydrochloride	Chain Drug Marketing Association Inc.	ANDA	Current
63941-939	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Valu Merchandisers Company	ANDA	Current
67091-247	Cetirizine Hydrochloride	Cetirizine Hydrochloride	WinCo Foods, LLC	ANDA	Current
68016-939	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Chain Drug Consortium, LLC	ANDA	Current
68071-2571	Cetirizine Hydrochloride	Cetirizine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68998-939	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Marc Glassman, Inc.	ANDA	Current
71141-133	Cetirizine Hydrochloride	Cetirizine Hydrochloride	LIDL US, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31251	ORIG	2008-01-09
39533	ORIG	2008-01-08