Application 077279

Type: ANDA
Sponsor: TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	SYRUP;ORAL	5MG/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A077279-001	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL			2008-05-27

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 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-05-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-05-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-05-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-05-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-05-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-05-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-05-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-05-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-05-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-05-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-05-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-05-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-05-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-05-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-05-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-05-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-05-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-05-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077279-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077279-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077279-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077279-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077279-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077279-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077279-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077279-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077279-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077279-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077279-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077279-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077279-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077279-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077279-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077279-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077279-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077279-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077279-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077279-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077279-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077279-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077279-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077279-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077279-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077279-001	AA	1	`cb3db0bc1861…`

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 14 · 271 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Zyrtec	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	9d8e78ea-af98-4f7c-8db5-044b49582f80	2025-10-10	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	6685a843-9dbe-4f9e-b75b-fe0e258f4155	2025-10-08	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	06cdcbe0-6c7c-4b91-8158-08ef2e0876dc	2025-10-08	Warnings	Name fallback brand name: CETIRIZINE HYDROCHLORIDE generic name: CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	c6f08e78-10fc-48d0-a3e1-e227081548eb	2025-10-07	Warnings	Name fallback brand name: CETIRIZINE HYDROCHLORIDE generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE ALLERGY	LEADER/ CARDINAL HEALTH 110, INC.	0cab7aa8-ded3-46f1-b801-2663cc9b0173	2025-10-03	Warnings	Name fallback brand name: Cetirizine Hydrochloride
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Aventura Pharmaceuticals, LLC	aeb73ab9-3b05-4062-a7fd-352cf2094a56	2025-10-02	Adverse reactions	Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Marlex Pharmaceuticals, Inc	eb917099-fecf-6b55-e053-2995a90aaafa	2025-09-23	Warnings	Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE
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 brand name: Cetirizine Hydrochloride 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 brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	BAJAJ MEDICAL, LLC	3b5908f1-faba-c317-e063-6294a90aa8a7	2025-08-01	Adverse reactions	Name fallback brand name: CETIRIZINE HYDROCHLORIDE 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 brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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