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 1.

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 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079191-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079191-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079191-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079191-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079191-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-04-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079191-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-04-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079191-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-04-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079191-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-04-15	`d06236e962d9…`

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 14 · 268 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
QUZYTTIR	CETIRIZINE HYDROCHLORIDE	ESTEVE PHARMACEUTICALS, S.A.	573770f6-b76e-f6ba-e063-6294a90aa54d	2026-07-30	Warnings, Adverse reactions	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
dg health all day allergy	CETIRIZINE HYDROCHLORIDE	Dolgencorp Inc	b9ac489a-80ed-4077-b68e-d03df1b892a6	2026-07-28	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
allergy relief	CETIRIZINE HYDROCHLORIDE	H E B	8649fc1e-ad56-4660-bbbb-8f1ed795697b	2026-07-20	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	KROGER COMPANY	b92d959d-dd35-b2a3-e053-2995a90af3ff	2026-07-15	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine hydrochloride - HIVES	CETIRIZINE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	562b5e6c-6103-df3d-e063-6394a90a897d	2026-07-14	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	Granules India Ltd	6efd5a60-e281-43f9-a52c-a95f46fbcbfc	2026-07-14	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	67207357-5f8a-4424-9901-d2717a43cf1b	2026-07-14	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Select Consumer Group	568960cf-2c8f-f1b0-e063-6294a90aebc7	2026-07-13	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape)	CETIRIZINE HYDROCHLORIDE	MARKSANS PHARMA LIMITED	652b0c65-a3f2-4454-9cf2-51a3389282cc	2026-07-10	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	f2f42f36-6b09-4140-e053-2a95a90af813	2026-06-29	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Equate Childrens Allergy Relief	CETIRIZINE HYDROCHLORIDE	Wal-Mart Stores Inc	b73950f4-af6f-4dc7-bce2-9ec43c45eee5	2026-06-12	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Childrens Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	30cbaa91-2216-efd2-e063-6294a90aaaed	2026-06-07	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	OHM LABORATORIES INC.	97802669-b4bd-4807-b3c1-6c6f5a2b0c67	2026-06-03	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	First Nation Group, LLC	5267f7c0-e62f-35da-e063-6394a90a9346	2026-06-03	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Savings Distributors LLC	5490c38a-91d7-9ee1-e063-6394a90a1ea5	2026-06-01	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
HEB Allergy Relief	CETIRIZINE HYDROCHLORIDE	H E B	9abdae64-4c3d-47f3-8224-fc81f7bfe557	2026-05-31	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Allergy Relief	CETIRIZINE HYDROCHLORIDE	AAA PHARMACEUTICAL, INC.	ac22558b-5c82-4ab9-95b8-53eedea46282	2026-05-28	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	c1ae7bb1-e154-4745-b01e-bc91d50d35c8	2026-05-25	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Allergy Relief	CETIRIZINE HYDROCHLORIDE	Grocery Outlet, Inc	441d049c-8844-955e-e063-6294a90a666d	2026-05-21	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetrizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	APOZEAL PHARMACEUTICALS INC	9c0549cf-4c93-45d9-9eac-3948fa45554e	2026-05-18	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE

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