Application 078398

Type: ANDA
Sponsor: PERRIGO PHARMS CO

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	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A078398-001	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-06-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078398-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-06-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-06-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-06-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-06-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-06-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-06-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-06-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-06-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-06-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078398-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078398-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078398-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078398-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078398-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078398-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078398-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078398-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078398-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078398-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078398-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078398-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078398-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078398-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078398-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078398-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078398-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078398-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078398-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078398-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078398-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078398-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078398-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078398-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078398-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078398-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078398-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078398-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078398-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078398-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078398-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078398-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078398-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078398-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078398-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078398-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078398-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078398-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078398-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078398-001	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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	e874264a-becc-45d0-b934-779eab5f5085	2026-03-25	Adverse reactions	Exact identifier application applno (ANDA): 078398 application number: ANDA078398
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Padagis Israel Pharmaceuticals Ltd	2f47dbc5-dfb4-425c-9fe4-777fa3c4e72e	2025-05-29	Adverse reactions	Exact identifier application applno (ANDA): 078398 application number: ANDA078398 ndc (product): 45802-626

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-878	Cetirizine	Cetirizine	Rebel Distributors Corp	ANDA	Current
45802-626	Cetirizine Hydrochloride	Cetirizine hydrochloride	Perrigo New York Inc	ANDA	Current
45802-626	Cetirizine Hydrochloride	Cetirizine hydrochloride	Perrigo New York Inc	ANDA	Current
45802-626	Cetirizine Hydrochloride	Cetirizine hydrochloride	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
50090-4288	Cetirizine Hydrochloride	Cetirizine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4288	Cetirizine Hydrochloride	Cetirizine hydrochloride	A-S Medication Solutions	ANDA	Current
63629-2521	Cetirizine Hydrochloride	Cetirizine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2521	Cetirizine Hydrochloride	Cetirizine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2521	Cetirizine Hydrochloride	Cetirizine hydrochloride	Bryant Ranch Prepack	ANDA	Current
68151-1008	Cetirizine Hydrochloride	Cetirizine hydrochloride	Carilion Materials Management	ANDA	Current