Application 205564

Type: ANDA
Sponsor: MACLEODS PHARMS LTD

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 42.

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
A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB		2016-01-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205564-001	AB

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A205564-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205564-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205564-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205564-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205564-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205564-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205564-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205564-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205564-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205564-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205564-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205564-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205564-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205564-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205564-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205564-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205564-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205564-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205564-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205564-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205564-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205564-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205564-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205564-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205564-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205564-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205564-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205564-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205564-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205564-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205564-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205564-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205564-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205564-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205564-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205564-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205564-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205564-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205564-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205564-001	AB	1	`e64feba35796…`

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	Bryant Ranch Prepack	1b593c65-2866-45d9-9c94-ac181f4cbc51	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205564 application number: ANDA205564 ndc (product): 71335-0418
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	Macleods Pharmaceuticals Limited	8a3c06a5-4a9a-4205-8ae7-c58efeb73c58	2025-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205564 application number: ANDA205564 ndc (product): 33342-200
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	Preferred Pharmaceuticals Inc.	5d6941c7-ef0a-48d3-93dc-53bc2c9789de	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205564 application number: ANDA205564

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
33342-200	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	Macleods Pharmaceuticals Limited	ANDA	Current
33342-200	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	Macleods Pharmaceuticals Limited	ANDA	Current
33342-200	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	Macleods Pharmaceuticals	ANDA	Current
63629-8069	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
68071-4629	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7189	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7189	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7189	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-2146	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-2146	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-2146	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70934-235	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-235	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-0418	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-0418	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current