Application 209274

Type: ANDA
Sponsor: GRANULES INDIA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL			2017-12-22

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 2 · 43 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	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`f41ea6bd6efb…`

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 3 · 56 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	CETIRIZINE HYDROCHLORIDE	LIDL US LLC	e5fd935d-5b60-7270-e053-2995a90a7141	2026-09-09	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274 ndc (product): 71141-294
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	LIDL US LLC	bcbbcb24-2a58-917a-e053-2a95a90af9a9	2026-08-07	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274 ndc (product): 71141-194
Cetirizine hydrochloride - HIVES	CETIRIZINE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	562b5e6c-6103-df3d-e063-6394a90a897d	2026-07-14	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	Granules India Ltd	6efd5a60-e281-43f9-a52c-a95f46fbcbfc	2026-07-14	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Medline	CETIRIZINE HCL	Medline Industries, LP	a75cd557-e19b-fdd4-e053-2a95a90a8097	2026-06-04	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Allergy Relief	CETIRIZINE HYDROCHLORIDE	AAA PHARMACEUTICAL, INC.	ac22558b-5c82-4ab9-95b8-53eedea46282	2026-05-28	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Allergy Relief	CETIRIZINE HYDROCHLORIDE	Grocery Outlet, Inc	441d049c-8844-955e-e063-6294a90a666d	2026-05-21	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	TWIN MED, LLC	14317ee7-1061-4c2b-9427-3433e27f13f5	2026-04-01	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Allergy Relief	CETIRIZINE HCL	Bryant Ranch Prepack	7e4a2d02-c2b3-4a1f-8373-a0b0dec5ddea	2026-03-10	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
All Day Allergy Relief	CETIRIZINE HCL	P & L Development, LLC	c5dab2f3-8f95-4b85-995b-23b21c762ae8	2026-02-23	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
All Day Allergy Relief	CETIRIZINE HCL	Strategic Sourcing Services LLC	2965303e-bedc-41fb-af97-827c30575091	2026-01-05	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274 ndc (product): 70677-0057
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Granules USA, Inc.	c8d711cd-7214-c7d5-e053-2995a90a6b67	2025-12-22	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES,LLC.	9f04520e-161d-3f7b-e053-2a95a90a678d	2025-12-19	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274 ndc (product): 72476-764
Cetirizine HCL	CETIRIZINE HCL	Meijer	181c63dd-6ab8-909a-e063-6394a90af141	2025-12-19	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Cetirizine	CETIIRIZINE	CVS PHARMACY, INC	fd8f495a-9940-363b-e053-6294a90a1097	2025-12-19	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	SAFEWAY	ed0eecfb-85bf-63bf-e053-2995a90a0e03	2025-12-18	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Allergy Relief	CETIRIZINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	dc66bf53-820f-40a3-b5ef-c653dd375544	2025-12-11	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	d55dfce1-acef-3342-e053-2a95a90a4b83	2025-12-04	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
CAREALL Allergy Relief	CETIRIZINE HCL	New World Imports	d3411eec-05b1-49b3-86e8-bc47ac0ef6b7	2025-12-01	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Allergy Relief	CETIRIZINE HCL	Family Dollar (FAMILY WELLNESS)	b90b5ef2-5aa2-45ca-94b9-c9d9e5877e23	2025-09-25	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274

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 2 of 2 · 102 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70518-2731	Allergy Relief	CETIRIZINE HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-2731	Allergy Relief	CETIRIZINE HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-2886	Allergy Relief	Cetirizine HCl	REMEDYREPACK INC.	ANDA	Current
70518-2886	Allergy Relief	Cetirizine HCl	REMEDYREPACK INC.	ANDA	Current
70677-0057	All Day Allergy Relief	Cetirizine HCl	Strategic Sourcing Services LLC	ANDA	Current
70677-0057	All Day Allergy Relief	Cetirizine HCl	Strategic Sourcing Services LLC	ANDA	Current
70677-0057	All Day Allergy Relief	Cetirizine HCl	McKesson (Sunmark)	ANDA	Current
70692-139	Cetirizine hydrochloride	Cetirizine hydrochloride	Strive Pharmaceuticals Inc	ANDA	Current
70692-139	Cetirizine hydrochloride	Cetirizine hydrochloride	Strive Pharmaceuticals Inc	ANDA	Current
71141-194	Cetirizine Hydrochloride	Cetirizine hydrochloride	LIDL US LLC	ANDA	Current
71141-294	Allergy Relief	Cetirizine hydrochloride	LIDL US LLC	ANDA	Current
71309-005	Cetirizine hydrochloride	Cetirizine hydrochloride	Safrel Pharmaceuticals, LLC	ANDA	Current
72036-194	Allergy Relief	Cetirizine hydrochloride	HARRIS TEETER	ANDA	Current
72036-194	Allergy Relief	Cetirizine hydrochloride	HARRIS TEETER	ANDA	Current
72090-059	Allergy Relief	Cetirizine HCl	Pioneer Life Sciences, LLC	ANDA	Current
72476-194	ALLERGY RELIEF	Cetirizine hydrochloride	RETAIL BUSINESS SERVICES , LLC.	ANDA	Current
72476-194	ALLERGY RELIEF	Cetirizine hydrochloride	RETAIL BUSINESS SERVICES , LLC.	ANDA	Current
72476-764	Cetirizine Hydrochloride	Cetirizine Hydrochloride	RETAIL BUSINESS SERVICES,LLC.	ANDA	Current
72559-003	Curist Allergy Relief	Cetirizine hydrochloride	Little Pharma, Inc.	ANDA	Current
73581-202	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	YYBA CORP	ANDA	Current
73581-202	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	YYBA CORP	ANDA	Current
81522-194	Allergy Relief	Cetirizine hydrochloride	FSA STORE INC.	ANDA	Current