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 13 of 15 · 282 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Proficient Rx LP	d14feb90-3ca2-4d5b-825c-25fc2252ca38	2022-06-01	Warnings	Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	TIME CAP LABORATORIES, INC.	dfbddafb-9455-5805-e053-2a95a90ad0d9	2022-05-24	Warnings	Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	Proficient Rx LP	198ca875-bb8a-49d5-8809-7121ba119381	2022-04-01	Warnings	Name fallback brand name: cetirizine hydrochloride generic name: CETIRIZINE HYDROCHLORIDE
dg health all day allergy	CETIRIZINE HYDROCHLORIDE	Dolgencorp Inc	6baa66e7-93df-43d9-a301-5d9c14274c99	2022-04-01	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
allergy relief	CETIRIZINE HYDROCHLORIDE	Publix Super Markets Inc	268170c9-b6a7-4851-b7d3-33dd1d733e39	2022-03-07	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	487ae0f0-320c-4534-b9e2-0e215f167cea	2022-01-12	Warnings	Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE
basic care all day allergy	CETIRIZINE HYDROCHLORIDE	Amazon.com Services LLC	c3e987c5-7ca1-4514-aa0a-6668ff2937c5	2022-01-04	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Allergy Relief	CETIRIZINE HYDROCHLORIDE	Magno-Humphries, Inc.	f0a3e654-5fec-4f98-84da-4c30500633b4	2021-10-28	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
CareOne Allergy Relief	CETIRIZINE HYDROCHLORIDE	American Sales Company	833e8904-d37d-4478-af7c-8287f2d079a7	2021-08-16	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
ALLERGY RELIEF	CETIRIZINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	95bf367c-eea8-73f9-e053-2a95a90a3dea	2021-07-12	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
dg health all day allergy	CETIRIZINE HYDROCHLORIDE	Dolgencorp, LLC	ba7d3995-c992-457c-a628-f036d77cc638	2021-06-01	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
rexall all day allergy relief	CETIRIZINE HYDROCHLORIDE	Dolgencorp, LLC	4d79fb74-1895-4efe-8016-c0dd5ed10f7a	2021-06-01	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Ohm Laboratories Inc.	161c4122-2c89-46e6-a6ae-db088087330d	2021-05-21	Warnings	Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	KROGER COMPANY	b8b2af96-af48-5f63-e053-2995a90a7d7c	2021-05-06	Warnings	Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	c111f6f3-e190-447f-b4a4-e277af641483	2021-05-06	Warnings	Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	d9ebebb5-736a-4019-8c1a-030148de9d02	2021-05-06	Warnings	Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE
basic care all day allergy	CETIRIZINE HYDROCHLORIDE	Amazon.com Services LLC	af8ff570-8f72-4343-b7e1-e977221f5b01	2021-04-09	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	0b6e8c63-a76c-4184-a9cc-9691378c3ee5	2021-03-11	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
CHILDRENS ALLERGY RELIEF	CETIRIZINE HYDROCHLORIDE	Fred's, Inc.	55e799b2-e325-4286-aa9a-b88e99ab1146	2020-12-13	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
CHILDRENS ALLERGY RELIEF	CETIRIZINE HYDROCHLORIDE	C.D.M.A., Inc.	b4feed95-86ca-411c-99b5-773e485e752f	2020-12-13	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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