Application 077499

Type: ANDA
Sponsor: SUN PHARM INDS INC

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 44.

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
A077499-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2007-12-27
A077499-002	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2007-12-27
A077499-003	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2007-12-27
A077499-004	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 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A077499-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077499-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077499-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077499-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077499-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077499-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077499-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077499-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077499-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077499-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077499-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077499-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077499-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077499-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077499-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077499-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077499-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077499-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077499-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077499-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077499-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077499-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077499-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077499-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077499-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077499-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077499-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077499-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077499-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077499-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077499-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077499-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077499-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077499-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077499-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077499-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077499-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077499-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077499-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077499-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`2680178bc6a6…`

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 6 of 13 · 256 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
allergy relief	CETIRIZINE HYDROCHLORIDE	Safeway	c5e74b2c-7871-4f28-a77d-0d674b9b8c5e	2025-09-23	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
CVS Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	CVS Pharmacy	3d711302-dc4e-0a69-e063-6394a90ade10	2025-09-18	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Equaline all day allergy	CETIRIZINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	491fae66-83b6-4beb-945b-39b9e4e021c5	2025-09-18	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Good Sense all day allergy	CETIRIZINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc	0827643a-29b8-487a-a158-28976d672d4d	2025-09-12	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
ALLERGY	CETIRIZINE HYDROCHLORIDE	Kroger Company	bc020340-ef39-e49a-e053-2a95a90af810	2025-09-11	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Padagis Israel Pharmaceuticals Ltd	2f47dbc5-dfb4-425c-9fe4-777fa3c4e72e	2025-08-31	Adverse reactions	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
CareOne Allergy Relief	CETIRIZINE HYDROCHLORIDE	American Sales Company	533abfc1-226e-4a68-bfcc-ec046a4d5751	2025-08-25	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	6d81446e-f713-4ca4-af38-3d31cf618873	2025-08-01	Adverse reactions	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	BAJAJ MEDICAL, LLC	3b5908f1-faba-c317-e063-6294a90aa8a7	2025-08-01	Adverse reactions	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	2c1ecee3-c2c1-25a2-e063-6294a90aad54	2025-07-21	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
good neighbor pharmacy all day allergy	CETIRIZINE HYDROCHLORIDE	Amerisource Bergen	c568e388-60ab-47be-b362-7832b83d06ad	2025-07-21	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
leader all day allergy	CETIRIZINE HYDROCHLORIDE	Cardinal Health 110, LLC. dba Leader	ce1cef83-e9d1-4cd6-b0e7-b2eb9ce06ddf	2025-07-21	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Mylan Institutional Inc.	bd0dc7f6-5fb9-4381-bd81-b150b75a2c68	2025-07-18	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Discount Drug Mart, Inc	c7c7e496-3682-c764-88ef-d2a09823f71e	2025-07-16	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
childrens allergy	CETIRIZINE HYDROCHLORIDE	Publix Super Markets Inc	ae216d0b-8ccc-4cc4-82f4-4d0f3a256822	2025-07-15	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Premier Value Childrens Cetirizine	CETIRIZINE HYDROCHLORIDE	Pharmacy Value Alliance LLC	a4931f0b-86f2-42c5-b2df-b359bb46f44a	2025-07-11	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
24 hour allergy	CETIRIZINE HYDROCHLORIDE	Meijer Distribution Inc	2b03c026-3e8a-4283-981f-965bc084c03d	2025-07-10	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	STRATEGIC SOURCING SERVICES LLC	601c2846-30e7-40f1-96b4-64fbed719c0b	2025-07-10	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cabinet Allergy Relief Refill Cetirizine HCI	CETIRIZINE HYDROCHLORIDE	Cabinet Health P.B.C.	0eaf9d27-e221-4cdd-97bc-478c775e3d67	2025-07-03	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Childrens Cetirizine Hydrochloride Sugar Free Grape	CETIRIZINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	54d72d7a-1f5b-4b36-bf76-ab7aef6243ab	2025-07-02	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57664-540	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Caraco Pharmaceutical Laboratories, Ltd.	ANDA	Current
57664-541	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Caraco Pharmaceutical Laboratories, Ltd.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31252	ORIG	2008-01-09
39534	ORIG	2008-01-08