Application 090765

Type: ANDA
Sponsor: AMNEAL PHARMS

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 44.

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
A090765-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL			2009-10-07
A090765-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL			2009-10-07

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A090765-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2009-10-07	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A090765-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2009-10-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090765-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2009-10-07	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A090765-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2009-10-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090765-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2009-10-07	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090765-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2009-10-07	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090765-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2009-10-07	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090765-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2009-10-07	`a50c72e98297…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetirizine Hydrochloride	CETIRIZINE	Amneal Pharmaceuticals LLC	e01f0db4-1b49-4b6e-b2fc-61834897bdd3	2024-10-23	Warnings	Exact identifier application applno (ANDA): 090765 application number: ANDA090765 ndc (product): 65162-005
Cetirizine Hydrochloride	CETIRIZINE	Amneal Pharmaceuticals LLC	7d16ccca-6aa3-4575-9fa7-f57301801a81	2024-10-23	Warnings	Exact identifier application applno (ANDA): 090765 application number: ANDA090765 ndc (product): 65162-003

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65162-003	Cetirizine Hydrochloride	Cetirizine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-003	Cetirizine Hydrochloride	Cetirizine	Amneal Pharmaceuticals of New York, LLC	ANDA	Current
65162-003	Cetirizine Hydrochloride	Cetirizine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-003	Cetirizine Hydrochloride	Cetirizine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-005	Cetirizine Hydrochloride	Cetirizine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-005	Cetirizine Hydrochloride	Cetirizine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-005	Cetirizine Hydrochloride	Cetirizine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-005	Cetirizine Hydrochloride	Cetirizine	Amneal Pharmaceuticals of New York, LLC	ANDA	Current