Application 091263

Type: ANDA
Sponsor: L PERRIGO CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	SOLUTION;ORAL	2.5MG/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
A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091263-001	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	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`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	A091263-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091263-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091263-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091263-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091263-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091263-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091263-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091263-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091263-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091263-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091263-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091263-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091263-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091263-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091263-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091263-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091263-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091263-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091263-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091263-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091263-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091263-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091263-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091263-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091263-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091263-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091263-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091263-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091263-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091263-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091263-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091263-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091263-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091263-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091263-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091263-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091263-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091263-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091263-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091263-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Padagis Israel Pharmaceuticals Ltd	2965ef46-18db-4615-9dce-bfb0f0b3366a	2025-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091263 application number: ANDA091263 ndc (product): 45802-680
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Bryant Ranch Prepack	628c26f0-f6bb-4658-ba50-8ca04cd859cb	2024-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091263 application number: ANDA091263 ndc (product): 63629-2533
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Bryant Ranch Prepack	a9e7152c-0aa3-4355-8805-307e510ac86b	2023-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091263 application number: ANDA091263

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45802-680	levocetirizine dihydrochloride	Levocetirizine dihydrochloride	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-680	levocetirizine dihydrochloride	Levocetirizine dihydrochloride	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-680	levocetirizine dihydrochloride	Levocetirizine dihydrochloride	Perrigo New York Inc	ANDA	Current
45802-680	levocetirizine dihydrochloride	Levocetirizine dihydrochloride	Perrigo New York Inc	ANDA	Current
45802-680	levocetirizine dihydrochloride	Levocetirizine dihydrochloride	Perrigo New York Inc	ANDA	Current
63629-2533	levocetirizine dihydrochloride	Levocetirizine dihydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2533	levocetirizine dihydrochloride	Levocetirizine dihydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2533	levocetirizine dihydrochloride	Levocetirizine dihydrochloride	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9329	ORIG	2011-11-08