Application 090229

Type: ANDA
Sponsor: SYNTHON PHARMS

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
A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB		2010-11-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090229-001	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	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090229-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-11-26	`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	A090229-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090229-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090229-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090229-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090229-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090229-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090229-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090229-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090229-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090229-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090229-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090229-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090229-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090229-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090229-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090229-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090229-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090229-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090229-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090229-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090229-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090229-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090229-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090229-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090229-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090229-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090229-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090229-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090229-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090229-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090229-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090229-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090229-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090229-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090229-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090229-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090229-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090229-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090229-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090229-001	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 4 · 75 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Golden State Medical Supply, Inc.	163dcce7-4535-a596-e063-6394a90a634f	2026-08-13	Warnings, Adverse reactions	Name fallback brand name: levocetirizine dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
good sense levocetirizine	LEVOCETIRIZINE DIHYDROCHLORIDE	L. Perrigo Company	0b482364-a00a-4b95-975a-f403a3ae4d2e	2026-07-13	Warnings	Name fallback generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Dr. Reddy's Laboratories Inc.	1f722b84-08de-7e6a-41ac-2c9d9bb9fb43	2026-06-04	Warnings	Name fallback brand name: levocetirizine dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Bryant Ranch Prepack	8274ca80-e7d3-4f4f-9901-cc5c589b4fef	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: levocetirizine dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Bryant Ranch Prepack	be58ca52-ab5d-4656-bfe0-bd5766235968	2026-05-15	Warnings, Adverse reactions	Name fallback brand name: levocetirizine dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Farmacias De Similares TX LLC	4ed17484-5609-d993-e063-6294a90a82a2	2026-04-06	Warnings	Name fallback brand name: Levocetirizine Dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Bryant Ranch Prepack	c79d3668-5243-4627-ad2b-cc7c045df120	2026-03-31	Warnings, Adverse reactions	Name fallback brand name: levocetirizine dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	c2dbf151-5b3d-5dfb-e053-2995a90a4c19	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: levocetirizine dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	A-S Medication Solutions	d8b4b326-8be1-4404-9db7-636d86933139	2026-03-24	Warnings, Adverse reactions	Name fallback brand name: Levocetirizine Dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Xyzal Allergy 24HR	LEVOCETIRIZINE DIHYDROCHLORIDE	Chattem, Inc.	8be45c2a-1eca-4a00-81b9-f7babdbdcd41	2026-03-11	Warnings	Name fallback generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Sportpharm LLC	8c00c74f-4377-4f2c-943e-e55afa5a824f	2026-02-14		Name fallback brand name: Levocetirizine Dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Childrens Xyzal Allergy	LEVOCETIRIZINE DIHYDROCHLORIDE	Chattem, Inc.	a33f2704-d350-428b-b467-91f4775ce17f	2026-02-05	Warnings	Name fallback generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	Glenmark Pharmaceuticals Inc., USA	60ae7e0e-281c-40a3-a0d3-259b843ddaaa	2026-01-22	Warnings, Adverse reactions	Name fallback brand name: LEVOCETIRIZINE DIHYDROCHLORIDE generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	KROGER COMPANY	e47658af-e0f3-5765-f568-300ba407dc29	2026-01-20	Warnings	Name fallback brand name: levocetirizine dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	CVS PHARMACY	c8681ca3-27b4-6738-af72-599ff05f2ec8	2026-01-20	Warnings	Name fallback brand name: levocetirizine dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Walgreens Company	766b8836-74b8-8af7-b900-b813b4fc175b	2026-01-20	Warnings	Name fallback brand name: levocetirizine dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
24HR Allergy Relief	LEVOCETIRIZINE DIHYDROCHLORIDE	LEADER/ Cardinal Health 110, Inc.	6ba57f12-fd25-c4a6-ff2d-2955116f84c4	2026-01-20	Warnings	Name fallback generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Allergy Relief	LEVOCETIRIZINE DIHYDROCHLORIDE	Albertsons Companies	e1a6932b-d076-6573-5b88-7b06c3a91681	2026-01-20	Warnings	Name fallback generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	SAM'S WEST INC	bb8d38b2-117a-fc6b-4ba0-0bc0188cbcd1	2026-01-19	Warnings	Name fallback brand name: levocetirizine dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45802-594	levocetirizine dihydrochloride	levocetirizine dihydrochloride	Perrigo New York Inc	ANDA	Current
63672-0051	Levocetirizine dihydrochloride	Levocetirizine dihydrochloride	Synthon Pharmaceuticals, Inc.	ANDA	Current
71205-204	levocetirizine dihydrochloride	levocetirizine dihydrochloride	Proficient Rx LP	ANDA	Current
71205-204	levocetirizine dihydrochloride	levocetirizine dihydrochloride	Proficient Rx LP	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31457	ORIG	2010-12-03