Application 077279

Type: ANDA
Sponsor: TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	SYRUP;ORAL	5MG/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A077279-001	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL			2008-05-27

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-05-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-05-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-05-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-05-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-05-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-05-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-05-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-05-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-05-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-05-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-05-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-05-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-05-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-05-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-05-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-05-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-05-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-05-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077279-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-05-27	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077279-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077279-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077279-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077279-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077279-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077279-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077279-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077279-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077279-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077279-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077279-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077279-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077279-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077279-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077279-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077279-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077279-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077279-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077279-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077279-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077279-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077279-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077279-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077279-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077279-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077279-001	AA	1	`cb3db0bc1861…`

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 14 of 14 · 271 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Chain Drug Consortium, LLC	9d7d2342-a594-4851-810b-b7bce1bd07dc	2018-08-24	Warnings	Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Valu Merchandisers Company	4a8d2887-8ac3-4d54-9e67-4a271d416426	2018-08-23	Warnings	Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE
Quality Choice Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Chain Drug Marketing Association Inc.	2e8cc4e3-8386-42de-801f-fef37f612849	2018-08-22	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Marc Glassman, Inc.	f30900e6-425f-43e0-81b6-1fa3bd321f0b	2018-06-20	Warnings	Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE
Allergy Relief	CETIRIZINE HYDROCHLORIDE	H E B	fdd3f9a0-b4be-498a-b8e0-1a9740399736	2018-05-09	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Childrens Allergy Relief	CETIRIZINE HYDROCHLORIDE	Wal-Mart Stores Inc	0d026538-5708-4030-b65d-18790e72059a	2018-02-14	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	LIDL US, LLC	a210d6b7-0829-4120-bb6d-fee0c2e57b26	2018-01-09	Warnings	Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	FAMILY DOLLAR SERVICES, INC	b326dacc-6123-47a7-9fde-6909db1d780b	2018-01-08	Warnings	Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE
Childrens Cetirzine	CETIRIZINE HYDROCHLORIDE	Pharmacy Value Alliance LLC	6b22f568-7ebd-4479-b764-6e5481d8c15a	2017-06-12	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Sandoz Inc	760dd0e4-280a-4d95-8938-cecaa7ec75f2	2013-06-03	Warnings	Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Dr.Reddy's Laboratories Limited	de152651-bfcd-856a-8329-a2ac93a376bc	2011-09-30	Warnings	Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.