Application 090486

Type: ANDA
Sponsor: FOSUN PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	TABLET;ORAL	5MG	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
A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL			2013-03-26

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	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090486-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2013-03-26	`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 2 of 4 · 75 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Target Corporation	7e933c85-96b0-b103-e26a-1aa8a1ded58e	2026-01-19	Warnings	Name fallback brand name: levocetirizine dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	HEB	b13ab6fc-4fec-c870-2c5f-b5e31dec722a	2026-01-19	Warnings	Name fallback brand name: levocetirizine dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Dr. Reddy's Laboratories Inc.	fb0a3619-9d5b-5c58-82f3-31f031672f33	2026-01-19	Warnings	Name fallback brand name: levocetirizine dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Walmart Inc.	82da5fa1-3633-2c48-32b9-d15482f308a1	2026-01-19	Warnings	Name fallback brand name: Levocetirizine Dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Northwind Health Company, LLC	f2b458d6-ac10-0fed-e053-2a95a90a0f9c	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Levocetirizine Dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Northwind Health Company, LLC	dae403cd-b6fc-7c50-e053-2995a90a95e3	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: levocetirizine dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Rite Aid Corporation	fafc8149-d59a-1253-ae79-f33a088e3769	2025-12-10	Warnings	Name fallback brand name: levocetirizine dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	BJWC (Berkley & Jensen / BJ'S)	0216f644-767c-ae88-f48f-cd29ac1547ed	2025-12-10	Warnings	Name fallback brand name: levocetirizine dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Chain Drug Marketing Association INC	61fb8bef-d868-adee-3237-d3268d603ba6	2025-12-10	Warnings	Name fallback brand name: levocetirizine dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Allergy Relief	LEVOCETIRIZINE DIHYDROCHLORIDE	AMERISOURCEBERGEN DRUG CORPORATION	fdf54de3-16a9-3b28-b4c4-d745322b3d3c	2025-12-10	Warnings	Name fallback generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	5036170d-7eeb-65a8-8473-7d98aeb51ee4	2025-12-10	Warnings	Name fallback brand name: levocetirizine dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	ScieGen Pharmaceuticals, Inc.	bd7fe481-dfe7-4dfd-aa05-6e2318a9234e	2025-10-16	Warnings, Adverse reactions	Name fallback brand name: levocetirizine dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Camber Pharmaceuticals, Inc.	dd407f8f-140d-489f-b8c5-f6602d87e247	2025-10-10	Warnings, Adverse reactions	Name fallback brand name: Levocetirizine Dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
allergy relief	LEVOCETIRIZINE DIHYDROCHLORIDE	Rite Aid Corporation	c6f826a4-cb8d-4a9f-99cc-5041f65801ca	2025-10-09	Warnings	Name fallback generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Westminster Pharmaceuticals, LLC	85dcd6c0-7fb2-40b3-b07f-93bab169011d	2025-09-30	Warnings, Adverse reactions	Name fallback brand name: Levocetirizine Dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Bryant Ranch Prepack	b7bbffcb-5f56-4735-998a-eadd07dfa2cb	2025-09-17	Warnings, Adverse reactions	Name fallback brand name: Levocetirizine Dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	Bryant Ranch Prepack	1b593c65-2866-45d9-9c94-ac181f4cbc51	2025-09-15	Warnings, Adverse reactions	Name fallback brand name: LEVOCETIRIZINE DIHYDROCHLORIDE generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	344ba2d6-4e17-4cef-bd7b-248fbb1af3b6	2025-09-15	Warnings, Adverse reactions	Name fallback brand name: Levocetirizine Dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	Macleods Pharmaceuticals Limited	8a3c06a5-4a9a-4205-8ae7-c58efeb73c58	2025-08-22	Warnings, Adverse reactions	Name fallback brand name: LEVOCETIRIZINE DIHYDROCHLORIDE generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	4f43d057-cba8-4366-86ba-4be361e4c71f	2025-08-11	Warnings, Adverse reactions	Name fallback brand name: Levocetirizine Dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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