Application 205291

Type: ANDA
Sponsor: STRIDES PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	CAPSULE;ORAL	10MG	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
A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	CAPSULE / ORAL			2017-07-21

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	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`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
cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	Strides Pharma, Inc.	29c433eb-6cf4-4bcf-8b2a-0398fb4cdcba	2026-08-24	Warnings	Exact identifier application applno (ANDA): 205291 application number: ANDA205291 ndc (product): 59556-894
Allergy Relief	CETIRIZINE HCL	WALMART INC. (see also Equate)	41bc1339-7137-4472-b47b-a7a36e24a9bb	2025-04-29	Warnings	Exact identifier application applno (ANDA): 205291 application number: ANDA205291
All Day Allergy	CETIRIZINE HCL	Care One (American Sales Company)	01d0729f-11ef-4ec5-8d8e-2863407c3f95	2025-04-07	Warnings	Exact identifier application applno (ANDA): 205291 application number: ANDA205291

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
33992-0811	Allergy Relief	Cetirizine HCl	ASSURED / DOLLAR TREE (Greenbrier International, Inc.)	ANDA	Current
33992-0811	Allergy Relief	Cetirizine HCl	ASSURED / DOLLAR TREE (Greenbrier International, Inc.)	ANDA	Current
33992-0811	Allergy Relief	Cetirizine HCl	ASSURED / DOLLAR TREE (Greenbrier International, Inc.)	ANDA	Current
59556-769	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Strides Pharma Inc	ANDA	Current
59556-894	cetirizine hydrochloride	cetirizine hydrochloride	Strides Pharma Inc	ANDA	Current
59556-894	cetirizine hydrochloride	cetirizine hydrochloride	Strides Pharma Inc	ANDA	Current