Application 090750

Type: ANDA
Sponsor: AUROBINDO PHARMA

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 42.

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
A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL			2010-02-02
A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2010-02-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2010-02-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2010-02-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2010-02-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2010-02-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2010-02-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2010-02-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2010-02-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2010-02-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2010-02-02	`bb7c543d1eb4…`

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 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Allergy Relief	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	52dc28ac-4059-4b6c-8bbc-22aa479a549a	2026-03-09	Warnings	Exact identifier application applno (ANDA): 090750 application number: ANDA090750 ndc (product): 58602-422
Childrens Cetirizine Hydrochloride Allergy	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	4de4f544-79cd-4a89-aafb-f2e2688b3c81	2026-03-09	Warnings	Exact identifier application applno (ANDA): 090750 application number: ANDA090750 ndc (product): 58602-028
Childrens Cetirizine Hydrochloride Hives Relief	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	bd489217-bf7c-429b-a58c-426104f7e779	2025-12-16	Warnings	Exact identifier application applno (ANDA): 090750 application number: ANDA090750
Childrens Cetirizine Hydrochloride Hives Relief	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	e000848a-8bbe-4149-bdcb-d7b4b0bd4d0d	2025-12-09	Warnings	Exact identifier application applno (ANDA): 090750 application number: ANDA090750 ndc (product): 58602-030
CHILDRENS ALLERGY RELIEF	CETIRIZINE HYDROCHLORIDE	Fred's, Inc.	55e799b2-e325-4286-aa9a-b88e99ab1146	2020-12-13	Warnings	Exact identifier application applno (ANDA): 090750 application number: ANDA090750 ndc (product): 55315-354
CHILDRENS ALLERGY RELIEF	CETIRIZINE HYDROCHLORIDE	C.D.M.A., Inc.	b4feed95-86ca-411c-99b5-773e485e752f	2020-12-13	Warnings	Exact identifier application applno (ANDA): 090750 application number: ANDA090750 ndc (product): 63868-865

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55315-354	CHILDRENS ALLERGY RELIEF	Cetirizine Hydrochloride	Fred's, Inc.	ANDA	Current
55315-354	CHILDRENS ALLERGY RELIEF	Cetirizine Hydrochloride	Fred's, Inc.	ANDA	Current
55315-354	CHILDRENS ALLERGY RELIEF	Cetirizine Hydrochloride	Fred's, Inc.	ANDA	Current
58602-028	Childrens Cetirizine Hydrochloride Allergy	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-028	Childrens Cetirizine Hydrochloride Allergy	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-028	Childrens Cetirizine Hydrochloride Allergy	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-028	Childrens Cetirizine Hydrochloride Allergy	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-030	Childrens Cetirizine Hydrochloride Hives Relief	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-030	Childrens Cetirizine Hydrochloride Hives Relief	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-030	Childrens Cetirizine Hydrochloride Hives Relief	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-030	Childrens Cetirizine Hydrochloride Hives Relief	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-422	Childrens Allergy Relief	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-422	Childrens Allergy Relief	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-422	Childrens Allergy Relief	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-422	Childrens Allergy Relief	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-424	Childrens Allergy Relief	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-424	Childrens Allergy Relief	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-424	Childrens Allergy Relief	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-424	Childrens Allergy Relief	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
63868-865	CHILDRENS ALLERGY RELIEF	Cetirizine Hydrochloride	C.D.M.A., Inc.	ANDA	Current
63868-865	CHILDRENS ALLERGY RELIEF	Cetirizine Hydrochloride	C.D.M.A., Inc.	ANDA	Current
63868-865	CHILDRENS ALLERGY RELIEF	Cetirizine Hydrochloride	C.D.M.A., Inc.	ANDA	Current
63868-865	CHILDRENS ALLERGY RELIEF	Cetirizine Hydrochloride	C.D.M.A., Inc.	ANDA	Current
65862-422	Childrens Cetirizine Hydrochloride Allergy	Cetirizine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-443	Childrens Cetirizine Hydrochloride Hives Relief	Cetirizine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current