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 3 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	Amerifoods Trading Company	f6ce3cdf-2e6d-61e8-e053-6294a90af7d3	2023-11-02	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Allergy Relief	CETIRIZINE HYDROCHLORIDE	HARRIS TEETER	b8f68d9d-2d3a-414a-e053-2a95a90a15ec	2023-10-30	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Allergy Relief	CETIRIZINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	f7651ae0-b459-4540-a640-3c1e37190d18	2023-09-14	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	A-S Medication Solutions	84f42ff2-1f51-4cbe-a2bb-dc024d2ff1a4	2023-09-14	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	A-S Medication Solutions	f4da9adf-840d-4526-86a6-6666183fd107	2023-07-06	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Allergy Relief	CETIRIZINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	adcd0e8e-cca7-e1bb-e053-2995a90a83be	2023-05-17	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274 ndc (product): 41163-197
Crcle Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Innovus Pharmaceuticals, Inc.	640583b6-379d-4ad3-b00c-383377c54eed	2023-04-21	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Allergy Relief	CETIRIZINE HYDROCHLORIDE	WINCO FOODS, LLC	f45f5920-d82f-6549-e053-2995a90ad58a	2023-04-11	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Allergy Relief	CETIRIZINE HCL	CVS PHARMACY, INC	34c9e7b3-ccba-4f22-a4d3-20724e7de486	2023-02-17	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Allergy Relief	CETIRIZINE HYDROCHLORIDE	MARC GLASSMAN, INC.	951b6f19-15fe-45d7-e053-2995a90aa254	2022-10-06	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274 ndc (product): 68998-194
Allergy Relief	CETIRIZINE HCL	WinCo Foods, LLC	39a7d993-805d-4fe8-bc21-3b08e8f78b62	2022-05-11	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274 ndc (product): 67091-351
Allergy Relief	CETIRIZINE HYDROCHLORIDE	Magno-Humphries, Inc.	f0a3e654-5fec-4f98-84da-4c30500633b4	2021-10-28	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274 ndc (product): 54257-270
ALLERGY RELIEF	CETIRIZINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	95bf367c-eea8-73f9-e053-2a95a90a3dea	2021-07-12	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	Strive Pharmaceuticals Inc	a4ebeec7-0245-4f77-e053-2995a90a7e7f	2020-11-17	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
ALLERGY RELIEF	CETIRIZINE HYDROCHLORIDE	DISCOUNT DRUG MART	844e0e60-f293-4588-9f34-c866bdad6f53	2020-09-11	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274 ndc (product): 53943-194
Allergy Relief	CETIRIZINE HCL 10 MG	Allegiant Health	bef9e980-37b4-430d-8635-3354d578b3b8	2019-12-12	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274 ndc (product): 69168-396

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 2 · 102 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-0606	Wal-Zyr	Cetirizine HCl	Walgreens	ANDA	Current
0363-0606	Allergy Relief	Cetirizine HCl	Walgreens	ANDA	Current
0363-0606	Wal-Zyr	Cetirizine HCl	Walgreens	ANDA	Current
0363-0606	Wal-Zyr	Cetirizine HCl	Walgreens	ANDA	Current
0363-0606	Wal-Zyr	Cetirizine HCl	Walgreens	ANDA	Current
0363-9899	Cetirizine Hydrochloride	Cetirizine Hydrochloride	WALGREEN CO.	ANDA	Current
0363-9899	Cetirizine Hydrochloride	Cetirizine Hydrochloride	WALGREEN CO.	ANDA	Current
0363-9899	Cetirizine Hydrochloride	Cetirizine Hydrochloride	WALGREEN CO.	ANDA	Current
41163-197	Allergy Relief	Cetirizine hydrochloride	UNFI	ANDA	Current
47682-204	Medique Cetiramed	Cetirizine HCl	Unifirst First Aid Corporation	ANDA	Current
47682-204	Medique Cetiramed	Cetirizine HCl	Unifirst First Aid Corporation	ANDA	Current
47682-204	Medique Cetiramed	Cetirizine HCl	Unifirst First Aid Corporation	ANDA	Current
50066-396	Allergy Relief	Cetirizine HCl 10 mg	Genomma Labs USA, Inc	ANDA	Current
50066-396	Allergy Relief	Cetirizine HCl 10 mg	Genomma Labs USA, Inc	ANDA	Current
50090-3906	Allergy Relief	Cetirizine HCl	A-S Medication Solutions	ANDA	Current
50090-3906	Allergy Relief	Cetirizine HCl	A-S Medication Solutions	ANDA	Current
50090-3906	Allergy Relief	Cetirizine HCl	A-S Medication Solutions	ANDA	Current
51824-076	CAREALL Cetirizine HCl	Cetirizine	New World Imports	ANDA	Current
51824-076	CAREALL Cetirizine HCl	Cetirizine	New World Imports	ANDA	Current
53329-033	Medline	cetirizine hcl	Medline Industries, Inc.	ANDA	Current
53329-033	Medline	cetirizine hcl	Medline Industries, Inc.	ANDA	Current
53329-033	Medline	cetirizine hcl	Medline Industries, Inc.	ANDA	Current
53329-033	Medline	cetirizine hcl	Medline Industries, LP	ANDA	Current
53329-033	Medline	cetirizine hcl	Medline Industries, LP	ANDA	Current
53943-194	ALLERGY RELIEF	Cetirizine hydrochloride	DISCOUNT DRUG MART	ANDA	Current
54257-270	Allergy Relief	CETIRIZINE HYDROCHLORIDE	Magno-Humphries, Inc.	ANDA	Current
54257-270	Allergy Relief	CETIRIZINE HYDROCHLORIDE	Magno-Humphries, Inc.	ANDA	Current
54257-270	Allergy Relief	CETIRIZINE HYDROCHLORIDE	Magno-Humphries, Inc.	ANDA	Current
55315-806	Allergy Relief	Cetirizine HCl	Freds Inc	ANDA	Current
55315-806	Allergy Relief	Cetirizine HCl	Freds Inc	ANDA	Current
55315-806	Allergy Relief	Cetirizine HCl	Freds Inc	ANDA	Current
55681-302	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	TWIN MED, LLC	ANDA	Current
55681-302	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	TWIN MED, LLC	ANDA	Current
57344-194	Allergy Relief	Cetirizine hydrochloride	AAA PHARMACEUTICAL, INC.	ANDA	Current
57344-194	Allergy Relief	Cetirizine hydrochloride	AAA PHARMACEUTICAL, INC.	ANDA	Current
59726-806	All Day Allergy Relief	Cetirizine HCl	P & L Development, LLC	ANDA	Current
59726-806	All Day Allergy Relief	Cetirizine HCl	P & L Development, LLC	ANDA	Current
59726-806	All Day Allergy Relief	Cetirizine HCl	P & L Development, LLC	ANDA	Current
62011-0384	All Day Allergy Relief	Cetirizine HCl	Strategic Sourcing Services LLC	ANDA	Current
62011-0384	All Day Allergy Relief	Cetirizine HCl	McKesson (Health Mart)	ANDA	Current
62011-0384	All Day Allergy Relief	Cetirizine HCl	Strategic Sourcing Services LLC	ANDA	Current
62207-764	Cetirizine hydrochloride	Cetirizine hydrochloride	Granules India Ltd	ANDA	Current
62207-764	Cetirizine hydrochloride	Cetirizine hydrochloride	Granules India Ltd	ANDA	Current
62207-764	Cetirizine hydrochloride	Cetirizine hydrochloride	Granules India Ltd	ANDA	Current
62207-764	Cetirizine hydrochloride	Cetirizine hydrochloride	Granules India Ltd	ANDA	Current
63868-665	Allergy Relief	Cetirizine hydrochloride	CHAIN DRUG MARKETING ASSOCIATION INC.	ANDA	Current
63868-665	Allergy Relief	Cetirizine hydrochloride	CHAIN DRUG MARKETING ASSOCIATION INC.	ANDA	Current
63941-194	Allergy Relief	Cetirizine hydrochloride	VALU MERCHANDISERS COMPANY	ANDA	Current
66424-564	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	SDA Laboratories, Inc.	ANDA	Current
66715-6950	24 Hour Allergy	Cetirizine hydrochloride	Lil' Drug Store Products, Inc.	ANDA	Current
66715-6950	24 Hour Allergy	Cetirizine hydrochloride	Lil' Drug Store Products, Inc.	ANDA	Current
66715-6950	24 Hour Allergy	Cetirizine hydrochloride	Lil' Drug Store Products, Inc.	ANDA	Current
67091-351	Allergy Relief	Cetirizine HCl	WinCo Foods, LLC	ANDA	Current
67091-351	Allergy Relief	Cetirizine HCl	WinCo Foods, LLC	ANDA	Current
68016-294	Allergy Relief	Cetirizine hydrochloride	CHAIN DRUG CONSORTIUM	ANDA	Current
68210-0119	Cabinet Allergy Relief	Cetirizine Hydrochloride	Spirit Pharmaceutical LLC	ANDA	Current
68210-0119	CABINET Allergy Relief	Cetirizine Hydrochloride	Spirit Pharmaceutical LLC	ANDA	Current
68210-0119	CABINET Allergy Relief	Cetirizine Hydrochloride	Spirit Pharmaceutical LLC	ANDA	Current
68210-0119	CABINET Allergy Relief	Cetirizine Hydrochloride	Spirit Pharmaceutical LLC	ANDA	Current
68210-4219	Allergy Relief	Cetirizine Hydrochloride	Spirit Pharmaceutical LLC	ANDA	Current
68210-4230	Allergy Relief	Cetirizine Hydrochloride	Spirit Pharmaceutical LLC	ANDA	Current
68998-194	Allergy Relief	Cetirizine hydrochloride	MARC GLASSMAN, INC.	ANDA	Current
68998-194	Allergy Relief	Cetirizine hydrochloride	MARC GLASSMAN, INC.	ANDA	Current
69168-396	Allergy Relief	Cetirizine HCl 10 mg	Allegiant Health	ANDA	Current
69168-396	Allergy Relief	Cetirizine HCl 10 mg	Allegiant Health	ANDA	Current
69230-304	Allergy Relief	Cetirizine HCl	Camber Consumer Care	ANDA	Current
69230-304	Allergy Relief	Cetirizine HCl	Camber Consumer Care	ANDA	Current
69230-304	Allergy Relief	Cetirizine HCl	Camber Consumer Care	ANDA	Current
69230-304	Allergy Relief	Cetirizine HCl	Camber Consumer Care	ANDA	Current
69230-304	Allergy Relief	Cetirizine HCl	Camber Consumer Care	ANDA	Current
69230-304	Allergy Relief	Cetirizine HCl	Camber Consumer Care	ANDA	Current
69230-304	Allergy Relief	Cetirizine HCl	Camber Consumer Care	ANDA	Current
69729-139	Cetirizine hydrochloride	Cetirizine hydrochloride	OPMX LLC	ANDA	Current
69729-139	Cetirizine hydrochloride	Cetirizine hydrochloride	OPMX LLC	ANDA	Current
69848-006	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Granules USA, Inc.	ANDA	Current
70010-163	Cetirizine hydrochloride	Cetirizine hydrochloride	Granules Pharmaceuticals Inc.	ANDA	Current
70010-163	Cetirizine hydrochloride	Cetirizine hydrochloride	Granules Pharmaceuticals Inc.	ANDA	Current
70010-163	Cetirizine hydrochloride	Cetirizine hydrochloride	Granules Pharmaceuticals Inc.	ANDA	Current
70518-2731	Allergy Relief	CETIRIZINE HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-2731	Allergy Relief	CETIRIZINE HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current