Application 079191

Type: ANDA
Sponsor: TORRENT PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
004	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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A079191-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2010-04-15
A079191-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2010-04-15
A079191-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2010-04-15
A079191-004	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2010-04-15

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 5 · 172 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	A079191-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079191-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079191-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079191-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-04-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079191-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079191-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079191-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079191-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-04-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079191-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079191-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079191-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079191-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079191-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079191-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079191-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079191-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079191-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079191-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079191-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079191-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079191-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079191-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079191-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079191-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079191-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079191-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079191-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079191-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079191-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079191-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079191-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079191-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079191-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079191-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079191-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079191-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079191-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-04-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079191-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-04-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079191-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-04-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079191-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-04-15	`5bbf6a4d5a75…`

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 7 of 14 · 267 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Mylan Institutional Inc.	bd0dc7f6-5fb9-4381-bd81-b150b75a2c68	2025-07-18	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Discount Drug Mart, Inc	c7c7e496-3682-c764-88ef-d2a09823f71e	2025-07-16	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
childrens allergy	CETIRIZINE HYDROCHLORIDE	Publix Super Markets Inc	ae216d0b-8ccc-4cc4-82f4-4d0f3a256822	2025-07-15	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Premier Value Childrens Cetirizine	CETIRIZINE HYDROCHLORIDE	Pharmacy Value Alliance LLC	a4931f0b-86f2-42c5-b2df-b359bb46f44a	2025-07-11	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
24 hour allergy	CETIRIZINE HYDROCHLORIDE	Meijer Distribution Inc	2b03c026-3e8a-4283-981f-965bc084c03d	2025-07-10	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	STRATEGIC SOURCING SERVICES LLC	601c2846-30e7-40f1-96b4-64fbed719c0b	2025-07-10	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cabinet Allergy Relief Refill Cetirizine HCI	CETIRIZINE HYDROCHLORIDE	Cabinet Health P.B.C.	0eaf9d27-e221-4cdd-97bc-478c775e3d67	2025-07-03	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Childrens Cetirizine Hydrochloride Sugar Free Grape	CETIRIZINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	54d72d7a-1f5b-4b36-bf76-ab7aef6243ab	2025-07-02	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Sandoz Inc	a814a06b-96ed-4403-bbd7-fc1142988b50	2025-06-30	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Sandoz Inc	817d07cf-5e31-421f-9e95-943bae01f5b0	2025-06-30	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Allergy Relief	CETIRIZINE HYDROCHLORIDE	BETTER LIVING BRANDS, LLC	eb60ae7d-87db-7413-e053-2a95a90afd76	2025-06-28	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Morning Star OTC	3efa421d-ea70-4b1f-95d0-7c63b6c39580	2025-06-19	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
ZYRTEC Hives	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	31136e3a-94fa-0860-e063-6394a90a008d	2025-06-16	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
ZYRTEC HIVES	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	31400cb2-fe85-ef74-e063-6294a90a11fb	2025-06-16	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
kirkland signature aller tec allergy	CETIRIZINE HYDROCHLORIDE	Costco Wholesale Company	d4a688aa-02d4-4af6-9a91-ed31679cfaf8	2025-06-10	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	Bryant Ranch Prepack	ae93976d-de9b-43a6-b299-ce1f1ae8d6f8	2025-05-21	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	Advanced Rx LLC	737492bf-96bd-4f7c-aa42-4910746f44bb	2025-05-13	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	Bi-Mar	cbb270c3-34a4-4af8-9da0-2e545787cb55	2025-05-01	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
childrens allergy relief	CETIRIZINE HYDROCHLORIDE	Walgreen Company	5cdd59a0-4d23-4f51-9aca-d66a639f8472	2025-04-29	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	INNOVUS PHARMACEUTICALS, INC.	89db2c96-62f6-4e75-8f0d-321b44094c60	2025-04-28	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13668-030	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	Torrent Pharmaceuticals Limited	ANDA	Current
13668-030	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	Torrent Pharmaceuticals Limited	ANDA	Current
13668-590	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-590	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9234	ORIG	2010-04-19