Application 078617

Type: ANDA
Sponsor: ACTAVIS MID ATLANTIC

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 43.

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
A078617-001	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL			2010-02-02

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2010-02-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2010-02-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2010-02-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2010-02-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2010-02-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2010-02-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2010-02-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2010-02-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2010-02-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2010-02-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2010-02-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2010-02-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2010-02-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2010-02-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2010-02-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2010-02-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2010-02-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`f41ea6bd6efb…`

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 10 of 15 · 282 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	CETIRIZINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	6eb22b5a-ff30-44f8-aca2-3f73614515a8	2024-08-16	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	d0d8b376-9001-8776-e053-2a95a90ae651	2024-08-12	Warnings	Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE
childrens allergy relief	CETIRIZINE HYDROCHLORIDE	Safeway	5d3e4c52-b697-4b91-af28-124f74d937e5	2024-08-02	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE	Amneal Pharmaceuticals LLC	214936a2-adc4-422a-a8fe-4c3ce9e01f36	2024-07-31	Warnings	Name fallback brand name: Cetirizine Hydrochloride
Cetirizine Hydrochloride	CETIRIZINE	Amneal Pharmaceuticals LLC	273172b2-9aaf-46fb-a1ce-2961650eacd3	2024-07-31	Warnings	Name fallback brand name: Cetirizine Hydrochloride
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Bryant Ranch Prepack	4b192084-dfdc-47bc-a968-6f49e137b248	2024-07-25	Warnings	Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	A-S Medication Solutions	42c9636f-07af-44a3-8d84-c11e1b57783a	2024-07-02	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Proficient Rx LP	4ed61888-4b22-4e11-96e7-f70aa516db4f	2024-07-01	Adverse reactions	Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	NorthStar Rx LLC	c9d1e26f-c95a-4991-95fa-9ed6ed484fe2	2024-06-26	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	b53d5e8a-a30c-4025-aa72-d2776a112e3e	2024-06-24	Warnings	Name fallback brand name: Cetirizine hydrochloride generic name: CETIRIZINE HYDROCHLORIDE
SIMPLY RIGHT childrens cetirizine	CETIRIZINE HYDROCHLORIDE	Sam's West Inc	48b47541-cf0c-48a7-9a65-2158fd1284f1	2024-06-24	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	71448ab0-e23e-4cf7-940e-7d67e7362fb4	2024-06-19	Adverse reactions	Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	f4ba3e0c-e6b3-2596-e053-2a95a90ab850	2024-06-11	Warnings	Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE
up and up childrens allergy	CETIRIZINE HYDROCHLORIDE	Target Corporation	4b1ee9b1-d22e-4fb2-8dcd-912374da12d7	2024-06-06	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
up and up childrens allergy	CETIRIZINE HYDROCHLORIDE	Target Corporation	1f37c327-cd4c-4bc1-ae70-713569694e2e	2024-06-04	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Bryant Ranch Prepack	ddec7d64-ab3d-4ddd-9bcd-b7f4d2b46be7	2024-05-21	Warnings	Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	OPMX LLC	b452bca6-2c51-d0a1-e053-2995a90aff67	2024-05-17	Warnings	Name fallback brand name: Cetirizine hydrochloride generic name: CETIRIZINE HYDROCHLORIDE
AMAZON BASIC CARE ALL DAY ALLERGY RELIEF	CETIRIZINE HYDROCHLORIDE	Amazon.com Services LLC	113e66f1-b922-8533-e063-6294a90ab30e	2024-05-10	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Members Mark Allergy Relief	CETIRIZINE HYDROCHLORIDE	Sam's West Inc	379756fd-f92d-4773-94fd-2682fcbdfba2	2024-05-10	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
childrens allergy relief	CETIRIZINE HYDROCHLORIDE	Safeway	cfc3daa5-7248-4105-95ee-4e19199655ce	2024-04-30	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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