Application 090199

Type: ANDA
Sponsor: TEVA 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
A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB		2011-08-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090199-001	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	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`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	A090199-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090199-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090199-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090199-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090199-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090199-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090199-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090199-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090199-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090199-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090199-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090199-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090199-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090199-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090199-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090199-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090199-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090199-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090199-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090199-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090199-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090199-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090199-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090199-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090199-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090199-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090199-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090199-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090199-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090199-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090199-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090199-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090199-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090199-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090199-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090199-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090199-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090199-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090199-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090199-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	344ba2d6-4e17-4cef-bd7b-248fbb1af3b6	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090199 application number: ANDA090199 ndc (product): 43063-479
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	4f43d057-cba8-4366-86ba-4be361e4c71f	2025-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090199 application number: ANDA090199 ndc (product): 0093-7701
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Proficient Rx LP	9f83891c-2466-4972-b0f4-b92cc7337be3	2025-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090199 application number: ANDA090199
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	2787aaa2-5209-f7d5-e063-6294a90a7103	2024-11-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090199 application number: ANDA090199

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
0093-7701	Levocetirizine Dihydrochloride	Levocetirizine Dihydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7701	Levocetirizine Dihydrochloride	Levocetirizine Dihydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7701	Levocetirizine Dihydrochloride	Levocetirizine Dihydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7701	Levocetirizine Dihydrochloride	Levocetirizine Dihydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7701	Levocetirizine Dihydrochloride	Levocetirizine Dihydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
43063-479	Levocetirizine Dihydrochloride	Levocetirizine Dihydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-479	Levocetirizine Dihydrochloride	Levocetirizine Dihydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-479	Levocetirizine Dihydrochloride	Levocetirizine Dihydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-479	Levocetirizine Dihydrochloride	Levocetirizine Dihydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-479	Levocetirizine Dihydrochloride	Levocetirizine Dihydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-3698	Levocetirizine Dihydrochloride	Levocetirizine Dihydrochloride	A-S Medication Solutions	ANDA	Current
50090-3698	Levocetirizine Dihydrochloride	Levocetirizine Dihydrochloride	A-S Medication Solutions	ANDA	Current
50090-3698	Levocetirizine Dihydrochloride	Levocetirizine Dihydrochloride	A-S Medication Solutions	ANDA	Current
66336-720	Levocetirizine Dihydrochloride	Levocetirizine Dihydrochloride	Dispensing Solutions, Inc.	ANDA	Current
71335-1405	Levocetirizine Dihydrochloride	Levocetirizine Dihydrochloride	Bryant Ranch Prepack	ANDA	Current