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 4 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	A-S Medication Solutions	7c163007-7e0d-4d55-8ae1-89defe55580f	2023-12-27	Warnings, Adverse reactions	Name fallback brand name: Levocetirizine Dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Chartwell RX, LLC	b56652ad-2cf8-4ed0-bb66-0e832772c792	2023-10-12	Warnings, Adverse reactions	Name fallback brand name: Levocetirizine Dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Bryant Ranch Prepack	a9e7152c-0aa3-4355-8805-307e510ac86b	2023-09-26	Warnings, Adverse reactions	Name fallback brand name: levocetirizine dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Proficient Rx LP	7108ad0a-af1e-4172-b4ba-e5d9aaadfba7	2022-10-01	Warnings, Adverse reactions	Name fallback brand name: Levocetirizine Dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Proficient Rx LP	1ceff0e6-1e66-4494-b986-1bd23eb6813e	2022-03-01	Warnings, Adverse reactions	Name fallback brand name: Levocetirizine Dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Topcare All Day Allergy	LEVOCETIRIZINE DIHYDROCHLORIDE	Topco Associates LLC	393616df-52f1-4e77-b69c-8239ca193d5b	2022-02-21	Warnings	Name fallback generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
DG Health Allergy Relief	LEVOCETIRIZINE DIHYDROCHLORIDE	Dolgencorp, LLC	470fee97-daab-4967-9c0e-77bacfb2ccd8	2021-06-24	Warnings	Name fallback generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Camber Consumer Care Inc	be72dafb-62ae-40b2-874f-1d8920fad19d	2020-11-30		Name fallback brand name: Levocetirizine Dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
basic care allergy relief	LEVOCETIRIZINE DIHYDROCHLORIDE	Amazon.com Services LLC	fe965a15-7789-4ea5-b33e-2d3513409e1a	2020-11-02	Warnings	Name fallback generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Proficient Rx LP	f10cfe9a-1884-4a65-b827-8fd781fb75c4	2020-01-01	Warnings, Adverse reactions	Name fallback brand name: Levocetirizine Dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Proficient Rx LP	b84ccb27-9c52-43b9-9a46-8f52a571045e	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: levocetirizine dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Bryant Ranch Prepack	34541530-ae3b-4247-b08c-cd1c13e2e6a1	2019-06-11	Warnings, Adverse reactions	Name fallback brand name: levocetirizine dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Dr.Reddy's laboratories Ltd.	c40c1bb4-25ce-90cb-b8dd-6a4c54cddd4a	2018-12-06	Warnings, Adverse reactions	Name fallback brand name: levocetirizine dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Vensun Pharmaceuticals, Inc.	7a2ca8aa-ba0b-45b4-bdb3-651879350130	2018-07-13	Warnings, Adverse reactions	Name fallback brand name: levocetirizine dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Marlex Pharmaceuticals Inc	f5d8d6a6-6455-430b-8923-090e1ca2ae3b	2018-01-01	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.