Application 090378

Type: ANDA
Sponsor: ACTAVIS MID ATLANTIC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	SYRUP;ORAL	5MG/5ML	No	No
002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090378-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL			2008-05-09
A090378-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL			2008-05-09

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 3 · 86 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	A090378-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2008-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090378-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2008-05-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090378-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2008-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090378-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2008-05-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090378-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2008-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090378-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2008-05-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090378-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2008-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090378-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2008-05-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090378-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2008-05-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090378-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2008-05-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090378-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2008-05-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090378-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2008-05-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090378-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2008-05-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090378-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2008-05-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090378-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2008-05-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090378-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2008-05-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090378-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2008-05-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090378-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2008-05-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090378-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2008-05-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090378-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2008-05-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090378-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2008-05-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090378-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2008-05-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090378-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2008-05-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090378-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2008-05-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090378-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2008-05-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090378-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2008-05-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090378-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2008-05-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090378-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2008-05-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090378-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2008-05-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090378-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2008-05-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090378-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2008-05-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090378-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2008-05-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090378-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2008-05-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090378-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2008-05-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090378-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2008-05-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090378-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2008-05-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090378-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2008-05-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090378-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2008-05-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090378-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2008-05-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090378-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2008-05-09	`74a2ff9319b5…`

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 3 of 14 · 267 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	CVS Pharmacy, Inc.	b45c95f2-91c9-55b5-e053-2995a90a75b7	2026-05-04	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Childrens Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	CVS Pharmacy, Inc.	b955c7ed-29da-959f-e053-2a95a90a03d4	2026-05-04	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine	CETIRIZINE HYDROCHLORIDE	Major Pharmaceuticals	71db132d-dca4-47ef-8560-c68ad2258933	2026-05-04	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Safecor Health, LLC	734118ec-bf9a-4e58-b728-50b6c832b270	2026-05-01	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Zyrtec	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	dc613bd5-70fd-1d9b-e053-2995a90a41cd	2026-04-27	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Childrens Zyrtec	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	0fe77356-d945-46a0-882e-b3bbab784556	2026-04-22	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
All Day Allergy	CETIRIZINE HYDROCHLORIDE	HyVee Inc	8889af37-8345-4358-994d-7d8b847f4874	2026-04-22	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine	CETIRIZINE HYDROCHLORIDE	Cardinal Health 107, LLC	37c6d1e4-dd88-42a2-a828-539b68aa5dad	2026-04-16	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Goodmeds All Day Allergy Relief Cetirizine HCl	CETIRIZINE HYDROCHLORIDE	Cabinet Health P.B.C.	cd13a70e-b9e2-41be-97ea-f022442b6460	2026-04-08	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	TWIN MED, LLC	14317ee7-1061-4c2b-9427-3433e27f13f5	2026-04-01	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Allergy Relief Indoor and Outdoor Allergies	CETIRIZINE HYDROCHLORIDE	CVS Pharmacy	98f3f2c6-da18-4055-81f1-962261360f9b	2026-03-31	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	e874264a-becc-45d0-b934-779eab5f5085	2026-03-25	Adverse reactions	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	73122009-531b-4929-bf57-494a6fc65b73	2026-03-25	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	7e94be37-0971-44b3-9857-f56330d810b6	2026-03-25	Adverse reactions	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	Bryant Ranch Prepack	9c11dd22-cb17-4179-8c54-1d515bf662d2	2026-03-20	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	a7da81e1-8865-45c9-83c7-32fb8032ca2e	2026-03-19	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine	CETIRIZINE HYDROCHLORIDE	Bryant Ranch Prepack	7e158fd6-268d-4ffc-a410-d054090d54c5	2026-03-19	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	Advagen Pharma Ltd.,	0956baea-f0ad-4aac-9464-831840db9230	2026-03-06	Adverse reactions	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
QUZYTTIR	CETIRIZINE HYDROCHLORIDE	TerSera Therapeutics LLC	f33e859d-ebc9-4d4f-a57d-204c48760d20	2026-03-04	Warnings, Adverse reactions	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	ffbca2a4-8df0-4c85-adf9-9414cd706fb2	2026-02-26	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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