Application 078617

Type: ANDA
Sponsor: ACTAVIS MID ATLANTIC

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 43.

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
A078617-001	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL			2010-02-02

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 · 43 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	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2010-02-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2010-02-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2010-02-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2010-02-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2010-02-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2010-02-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2010-02-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2010-02-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2010-02-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2010-02-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2010-02-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2010-02-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2010-02-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2010-02-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2010-02-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2010-02-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2010-02-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078617-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2010-02-02	`f41ea6bd6efb…`

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 15 of 15 · 282 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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.