Application 210375

Type: ANDA
Sponsor: DR REDDYS LABS 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
A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL			2018-01-19

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Dr. Reddy's Laboratories Inc.	1f722b84-08de-7e6a-41ac-2c9d9bb9fb43	2026-06-04	Warnings	Exact identifier application applno (ANDA): 210375 application number: ANDA210375 ndc (product): 43598-735
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	KROGER COMPANY	e47658af-e0f3-5765-f568-300ba407dc29	2026-01-20	Warnings	Exact identifier application applno (ANDA): 210375 application number: ANDA210375 ndc (product): 30142-717
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	CVS PHARMACY	c8681ca3-27b4-6738-af72-599ff05f2ec8	2026-01-20	Warnings	Exact identifier application applno (ANDA): 210375 application number: ANDA210375 ndc (product): 69842-761
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Walgreens Company	766b8836-74b8-8af7-b900-b813b4fc175b	2026-01-20	Warnings	Exact identifier application applno (ANDA): 210375 application number: ANDA210375 ndc (product): 0363-5529
24HR Allergy Relief	LEVOCETIRIZINE DIHYDROCHLORIDE	LEADER/ Cardinal Health 110, Inc.	6ba57f12-fd25-c4a6-ff2d-2955116f84c4	2026-01-20	Warnings	Exact identifier application applno (ANDA): 210375 application number: ANDA210375 ndc (product): 70000-0362
Allergy Relief	LEVOCETIRIZINE DIHYDROCHLORIDE	Albertsons Companies	e1a6932b-d076-6573-5b88-7b06c3a91681	2026-01-20	Warnings	Exact identifier application applno (ANDA): 210375 application number: ANDA210375 ndc (product): 21130-732
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	SAM'S WEST INC	bb8d38b2-117a-fc6b-4ba0-0bc0188cbcd1	2026-01-19	Warnings	Exact identifier application applno (ANDA): 210375 application number: ANDA210375
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Target Corporation	7e933c85-96b0-b103-e26a-1aa8a1ded58e	2026-01-19	Warnings	Exact identifier application applno (ANDA): 210375 application number: ANDA210375 ndc (product): 11673-847
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	HEB	b13ab6fc-4fec-c870-2c5f-b5e31dec722a	2026-01-19	Warnings	Exact identifier application applno (ANDA): 210375 application number: ANDA210375 ndc (product): 37808-126
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Dr. Reddy's Laboratories Inc.	fb0a3619-9d5b-5c58-82f3-31f031672f33	2026-01-19	Warnings	Exact identifier application applno (ANDA): 210375 application number: ANDA210375 ndc (product): 43598-810
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Walmart Inc.	82da5fa1-3633-2c48-32b9-d15482f308a1	2026-01-19	Warnings	Exact identifier application applno (ANDA): 210375 application number: ANDA210375 ndc (product): 49035-492
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Rite Aid Corporation	fafc8149-d59a-1253-ae79-f33a088e3769	2025-12-10	Warnings	Exact identifier application applno (ANDA): 210375 application number: ANDA210375 ndc (product): 11822-5252
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	BJWC (Berkley & Jensen / BJ'S)	0216f644-767c-ae88-f48f-cd29ac1547ed	2025-12-10	Warnings	Exact identifier application applno (ANDA): 210375 application number: ANDA210375
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Chain Drug Marketing Association INC	61fb8bef-d868-adee-3237-d3268d603ba6	2025-12-10	Warnings	Exact identifier application applno (ANDA): 210375 application number: ANDA210375 ndc (product): 63868-473
Allergy Relief	LEVOCETIRIZINE DIHYDROCHLORIDE	AMERISOURCEBERGEN DRUG CORPORATION	fdf54de3-16a9-3b28-b4c4-d745322b3d3c	2025-12-10	Warnings	Exact identifier application applno (ANDA): 210375 application number: ANDA210375 ndc (product): 46122-531
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	5036170d-7eeb-65a8-8473-7d98aeb51ee4	2025-12-10	Warnings	Exact identifier application applno (ANDA): 210375 application number: ANDA210375 ndc (product): 41163-938

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-5528	levocetirizine dihydrochloride	levocetirizine dihydrochloride	Walgreens Company	ANDA	Current
0363-5528	levocetirizine dihydrochloride	levocetirizine dihydrochloride	Walgreens Company	ANDA	Current
0363-5529	levocetirizine dihydrochloride	levocetirizine dihydrochloride	Walgreens Company	ANDA	Current
0363-5529	levocetirizine dihydrochloride	levocetirizine dihydrochloride	Walgreens Company	ANDA	Current
0363-5529	levocetirizine dihydrochloride	levocetirizine dihydrochloride	Walgreens Company	ANDA	Current
0536-1144	levocetirizine dihydrochloride	levocetirizine dihydrochloride	RUGBY LABORATORIES	ANDA	Current
0536-1144	levocetirizine dihydrochloride	levocetirizine dihydrochloride	RUGBY LABORATORIES	ANDA	Current
11673-847	levocetirizine dihydrochloride	levocetirizine dihydrochloride	Target Corporation	ANDA	Current
11673-847	levocetirizine dihydrochloride	levocetirizine dihydrochloride	Target Corporation	ANDA	Current
11822-5252	levocetirizine dihydrochloride	levocetirizine dihydrochloride	Rite Aid Corporation	ANDA	Current
21130-732	Allergy Relief	levocetirizine dihydrochloride	Albertsons Companies	ANDA	Current
21130-732	Allergy Relief	levocetirizine dihydrochloride	Albertsons Companies	ANDA	Current
30142-717	levocetirizine dihydrochloride	levocetirizine dihydrochloride	KROGER COMPANY	ANDA	Current
37808-126	levocetirizine dihydrochloride	levocetirizine dihydrochloride	HEB	ANDA	Current
37808-126	levocetirizine dihydrochloride	levocetirizine dihydrochloride	HEB	ANDA	Current
41163-938	levocetirizine dihydrochloride	levocetirizine dihydrochloride	SUPERVALU INC.	ANDA	Current
41163-938	levocetirizine dihydrochloride	levocetirizine dihydrochloride	SUPERVALU INC.	ANDA	Current
43598-669	levocetirizine dihydrochloride	levocetirizine dihydrochloride	Dr. Reddy's Laboratories Inc.	ANDA	Current
43598-735	levocetirizine dihydrochloride	levocetirizine dihydrochloride	Dr. Reddy's Laboratories Inc.	ANDA	Current
43598-735	levocetirizine dihydrochloride	levocetirizine dihydrochloride	Dr. Reddy's Laboratories Inc.	ANDA	Current
43598-810	levocetirizine dihydrochloride	levocetirizine dihydrochloride	Dr. Reddy's Laboratories Inc.	ANDA	Current
46122-531	Allergy Relief	levocetirizine dihydrochloride	AMERISOURCEBERGEN DRUG CORPORATION	ANDA	Current
46122-531	Allergy Relief	levocetirizine dihydrochloride	AMERISOURCEBERGEN DRUG CORPORATION	ANDA	Current
46122-531	Allergy Relief	levocetirizine dihydrochloride	AMERISOURCEBERGEN DRUG CORPORATION	ANDA	Current
46122-531	Allergy Relief	levocetirizine dihydrochloride	AMERISOURCEBERGEN DRUG CORPORATION	ANDA	Current
46122-531	Allergy Relief	levocetirizine dihydrochloride	AMERISOURCEBERGEN DRUG CORPORATION	ANDA	Current
49035-492	Levocetirizine Dihydrochloride	Levocetirizine Dihydrochloride	Wal-Mart Stores Inc	ANDA	Current
63868-473	levocetirizine dihydrochloride	levocetirizine dihydrochloride	Chain Drug Marketing Association INC	ANDA	Current
69842-761	levocetirizine dihydrochloride	levocetirizine dihydrochloride	CVS PHARMACY	ANDA	Current
69842-761	levocetirizine dihydrochloride	levocetirizine dihydrochloride	CVS PHARMACY	ANDA	Current
69842-761	levocetirizine dihydrochloride	levocetirizine dihydrochloride	CVS PHARMACY	ANDA	Current
70000-0362	24HR Allergy Relief	levocetirizine dihydrochloride	CARDINAL HEALTH	ANDA	Current
70000-0362	24HR Allergy Relief	levocetirizine dihydrochloride	CARDINAL HEALTH	ANDA	Current
70000-0362	24HR Allergy Relief	levocetirizine dihydrochloride	CARDINAL HEALTH	ANDA	Current
81086-996	levocetirizine dihydrochloride	levocetirizine dihydrochloride	Global Distributors, Inc	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
51901	ORIG	2018-01-26