Application 211983

Type: ANDA
Sponsor: PERRIGO R AND D

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 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
A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL			2019-03-28

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
good sense levocetirizine	LEVOCETIRIZINE DIHYDROCHLORIDE	L. Perrigo Company	0b482364-a00a-4b95-975a-f403a3ae4d2e	2026-07-13	Warnings	Exact identifier application applno (ANDA): 211983 application number: ANDA211983 ndc (product): 0113-0241
allergy relief	LEVOCETIRIZINE DIHYDROCHLORIDE	Rite Aid Corporation	c6f826a4-cb8d-4a9f-99cc-5041f65801ca	2025-10-09	Warnings	Exact identifier application applno (ANDA): 211983 application number: ANDA211983 ndc (product): 11822-0241
allergy relief	LEVOCETIRIZINE DIHYDROCHLORIDE	Walgreen Company	5033f8e3-c1c4-44e9-a774-703d9b04e82c	2025-07-16	Warnings	Exact identifier application applno (ANDA): 211983 application number: ANDA211983 ndc (product): 0363-3901
Allergy Relief	LEVOCETIRIZINE DIHYDROCHLORIDE	Meijer Distribution Inc	ca6d0ba0-96af-41e9-a3e9-0c7783db3011	2025-05-20	Warnings	Exact identifier application applno (ANDA): 211983 application number: ANDA211983 ndc (product): 41250-488
Topcare All Day Allergy	LEVOCETIRIZINE DIHYDROCHLORIDE	Topco Associates LLC	393616df-52f1-4e77-b69c-8239ca193d5b	2022-02-21	Warnings	Exact identifier application applno (ANDA): 211983 application number: ANDA211983 ndc (product): 36800-241
DG Health Allergy Relief	LEVOCETIRIZINE DIHYDROCHLORIDE	Dolgencorp, LLC	470fee97-daab-4967-9c0e-77bacfb2ccd8	2021-06-24	Warnings	Exact identifier application applno (ANDA): 211983 application number: ANDA211983 ndc (product): 55910-241
basic care allergy relief	LEVOCETIRIZINE DIHYDROCHLORIDE	Amazon.com Services LLC	fe965a15-7789-4ea5-b33e-2d3513409e1a	2020-11-02	Warnings	Exact identifier application applno (ANDA): 211983 application number: ANDA211983 ndc (product): 72288-241

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-0241	good sense levocetirizine	levocetirizine dihydrochloride	L. Perrigo Company	ANDA	Current
0363-2241	levocetirizine	levocetirizine dihydrochloride	Walgreen Company	ANDA	Current
0363-3901	allergy relief	levocetirizine dihydrochloride	Walgreen Company	ANDA	Current
11822-0241	allergy relief	levocetirizine dihydrochloride	Rite Aid Corporation	ANDA	Current
11822-0241	allergy relief	levocetirizine dihydrochloride	Rite Aid Corporation	ANDA	Current
36800-241	Topcare All Day Allergy	levocetirizine dihydrochloride	Topco Associates LLC	ANDA	Current
36800-241	Topcare All Day Allergy	levocetirizine dihydrochloride	Topco Associates LLC	ANDA	Current
36800-241	Topcare All Day Allergy	levocetirizine dihydrochloride	Topco Associates LLC	ANDA	Current
41250-488	Allergy Relief	levocetirizine dihydrochloride	Meijer Distribution Inc	ANDA	Current
55910-241	DG Health Allergy Relief	levocetirizine dihydrochloride	Dolgencorp, LLC	ANDA	Current
72288-241	basic care allergy relief	levocetirizine dihydrochloride	Amazon.com Services LLC	ANDA	Current