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 5 of 14 · 271 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	CETIRIZINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	dc66bf53-820f-40a3-b5ef-c653dd375544	2025-12-11	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	Bionpharma Inc.	831d4141-b3be-4d98-a372-9c4d57ad296c	2025-12-08	Warnings	Name fallback brand name: CETIRIZINE HYDROCHLORIDE generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine	CETIRIZINE HYDROCHLORIDE	A-S Medication Solutions	ff782956-03b7-4ae6-b78f-fb7fe78b262d	2025-12-05	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine	CETIRIZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	4a45672b-67d3-4739-86ec-0a6696dd83d4	2025-12-04	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
signature care allergy relief	CETIRIZINE HYDROCHLORIDE	Safeway	24099cbf-61ee-4ec8-a4ec-95a66ceaa0c0	2025-12-04	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	03c0a599-072a-10ef-e063-6394a90a9698	2025-11-20	Warnings	Name fallback brand name: cetirizine hydrochloride generic name: CETIRIZINE HYDROCHLORIDE
RIGHT REMEDIES ALL-DAY Allergy Relief	CETIRIZINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	8227edbe-88d5-4d79-9175-891dd9566357	2025-11-20	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
GOODNOW ALLERGY RELIEF	CETIRIZINE HYDROCHLORIDE	Gobrands, Inc	86ade508-8841-47d8-addb-418ecd6dc8de	2025-11-07	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	5481ccb3-b311-4b25-b923-4fe8522ea92b	2025-11-05	Warnings	Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE
Childrens Cetirizine Hydrochloride Sugar Free Grape	CETIRIZINE HYDROCHLORIDE	VERITYRX, LLC	42a1168e-e2cd-a1e5-e063-6294a90ab3b6	2025-11-02	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE TABLETS	VERITYRX, LLC	42778a1c-6894-8646-e063-6294a90a6cb5	2025-10-31	Warnings	Name fallback brand name: Cetirizine Hydrochloride
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	BluePoint Laboratories	a86fbe45-08db-bddf-e053-2a95a90aa792	2025-10-30	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine	CETIRIZINE HYDROCHLORIDE	VERITYRX, LLC	43f40b92-f0e0-8808-e063-6394a90a656b	2025-10-30	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine	CETIRIZINE HYDROCHLORIDE	A-S Medication Solutions	88c3d23e-a0d8-4464-9414-666d74f11f66	2025-10-28	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE TABLETS	Bryant Ranch Prepack	e4324124-13f8-4450-9fd6-686bd6e25578	2025-10-28	Warnings	Name fallback brand name: Cetirizine Hydrochloride
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Bionpharma Inc.	41d7af88-87b4-370e-e063-6294a90a8af6	2025-10-24	Adverse reactions	Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE
ValuMeds All Day Allergy Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Cabinet Health P.B.C.	3071238a-6b35-4da8-8305-eced56c513ce	2025-10-23	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
ZYRTEC Allergy	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	0face45c-af24-3559-e063-6294a90abde5	2025-10-21	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	BAJAJ MEDICAL, LLC	05324e41-ee3f-0e4b-e063-6294a90a102c	2025-10-16	Adverse reactions	Name fallback brand name: CETIRIZINE HYDROCHLORIDE generic name: CETIRIZINE HYDROCHLORIDE
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	b165db38-b302-4220-8627-77cb07bb078c	2025-10-10	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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