Application 078488

Type: ANDA
Sponsor: BRECKENRIDGE

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
A078488-001	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		2008-10-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A078488-001	AA

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	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-10-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-10-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-10-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-10-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-10-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078488-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078488-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078488-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078488-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078488-001	AA	1	`6a471c1ec25d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078488-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078488-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078488-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078488-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078488-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078488-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078488-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078488-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078488-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078488-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078488-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078488-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078488-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078488-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078488-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078488-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078488-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078488-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078488-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078488-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078488-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078488-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078488-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078488-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078488-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078488-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078488-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078488-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078488-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078488-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078488-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078488-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078488-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078488-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A078488-001	AA	1	`a50c72e98297…`

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Bionpharma Inc.	41d7af88-87b4-370e-e063-6294a90a8af6	2025-10-24	Adverse reactions	Exact identifier application applno (ANDA): 078488 application number: ANDA078488

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 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
33261-924	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Aidarex Pharmaceuticals LLC	ANDA	Current
50090-2084	Cetirizine Hydrochloride	Cetirizine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2084	Cetirizine Hydrochloride	Cetirizine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2084	Cetirizine Hydrochloride	Cetirizine Hydrochloride	A-S Medication Solutions	ANDA	Current
51991-837	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-837	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-837	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-837	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Breckenridge Pharmaceutical, Inc.	ANDA	Current
53217-163	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Aidarex Pharmaceuticals LLC	ANDA	Current
63187-436	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Proficient Rx LP	ANDA	Current
63187-436	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Proficient Rx LP	ANDA	Current
63629-2060	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2060	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
68151-3708	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Carilion Materials Management	ANDA	Current
68788-9493	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current