Application 210622

Type: ANDA
Sponsor: HETERO LABS LTD III

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL			2019-03-13

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 2 of 2 · 44 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	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2019-03-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2019-03-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2019-03-13	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2019-03-13	`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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CHILDRENS ALLERGY RELIEF	CETIRIZINE HYDROCHLORIDE	Camber Consumer Care Inc	941e4aa9-6388-424c-87ad-3ea2ec5aafea	2024-03-27	Warnings	Exact identifier application applno (ANDA): 210622 application number: ANDA210622 ndc (product): 69230-316
CHILDRENS ALLERGY RELIEF	CETIRIZINE HYDROCHLORIDE	A-S Medication Solutions	a6492645-8438-4e82-aa31-7e5b4bccb220	2023-12-15	Warnings	Exact identifier application applno (ANDA): 210622 application number: ANDA210622 ndc (product): 50090-4741
CHILDRENS ALLERGY RELIEF	CETIRIZINE HYDROCHLORIDE	Strategic Sourcing Services	1dd63ede-37ca-4b5a-bfed-1aca5dd15424	2022-07-27	Warnings	Exact identifier application applno (ANDA): 210622 application number: ANDA210622 ndc (product): 70677-0149

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-4741	CHILDRENS ALLERGY RELIEF	cetirizine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4741	CHILDRENS ALLERGY RELIEF	cetirizine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4741	CHILDRENS ALLERGY RELIEF	cetirizine hydrochloride	A-S Medication Solutions	ANDA	Current
69230-316	CHILDRENS ALLERGY RELIEF	cetirizine hydrochloride	Camber Consumer Care	ANDA	Current
70677-0149	CHILDRENS ALLERGY RELIEF	cetirizine hydrochloride	Strategic Sourcing Services	ANDA	Current