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 8 of 14 · 267 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
childrens allergy relief	CETIRIZINE HYDROCHLORIDE	Walgreen Company	2a62f905-663f-4aae-991f-a368b5120f6f	2025-04-24	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Childrens Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	a1edc2e6-3661-4d7a-884c-709d73cb89e0	2025-04-22	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	6a962a1c-c197-492b-bfa6-e0c28eda1533	2025-04-11	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Childrens Zyrtec	CETIRIZINE HYDROCHLORIDE	A-S Medication Solutions	0adb3617-3528-4d64-a9ad-b4545ec9d7b9	2025-04-08	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Childrens Zyrtec	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	013ce40e-37c9-4b84-b530-ed895f60ce0e	2025-04-07	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cabinet All Day Allergy Relief	CETIRIZINE HYDROCHLORIDE	Cabinet Health P.B.C.	889316bc-5f98-426a-9750-2fdb0c427408	2025-04-07	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
basic care all day allergy	CETIRIZINE HYDROCHLORIDE	Amazon.com Services LLC	e71e259a-494e-4a9a-b0e4-25bd25dd0e07	2025-04-06	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	WALGREEN CO.	3d2eac7f-db44-4771-8c7e-a38e68a7f24b	2025-04-05	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	Bryant Ranch Prepack	0dc5a72f-1cc4-4cfc-a969-0ed781f7aa6f	2025-04-03	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Allergy Relief	CETIRIZINE HYDROCHLORIDE	FSA STORE INC.	ec6b4e86-ac27-e1f2-e053-2a95a90ab3e1	2025-03-07	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Umasuto, LLC	9af4ab23-d6d3-43f9-a026-76fd9771963f	2025-03-06	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	Padagis Israel Pharmaceuticals Ltd	91fe3ab8-c155-4482-9f06-f029d3563aad	2025-03-06	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
CHILDRENS ZYRTEC	CETIRIZINE HYDROCHLORIDE	A-S Medication Solutions	5c19a07e-09f4-46ed-939c-d21fe3e811f6	2025-03-03	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.	a9b21d71-106e-4bd5-aaab-9254c8a44e0d	2025-02-12	Adverse reactions	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
ValuMeds 24-Hour Allergy Relief	CETIRIZINE HYDROCHLORIDE	Cabinet Health P.B.C.	fcb87d13-3385-4f4c-8d5e-6ba58e952e4e	2025-01-27	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	RedPharm Drug Inc	f4c1f9fd-2d32-71d3-e053-2a95a90a3ba4	2025-01-23	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	Padagis Israel Pharmaceuticals Ltd	c2cf555d-986c-4e89-ac4f-938e92c418e2	2025-01-20	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
CABINET Allergy Relief	CETIRIZINE HYDROCHLORIDE	Spirit Pharmaceutical LLC	e49c3c91-aab8-478e-97fa-04ed06180021	2024-12-30	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Allergy Relief	CETIRIZINE HYDROCHLORIDE	Spirit Pharmaceutical LLC	507df969-804c-4e95-bb42-c1224fce2b28	2024-12-30	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Rite Aid childrens allergy relief	CETIRIZINE HYDROCHLORIDE	Rite Aid Corporation	edbefbee-26b6-46bc-abcc-f7b2817705e5	2024-12-19	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