Application 202046

Type: ANDA
Sponsor: MICRO LABS LTD INDIA

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
A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-09-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202046-001	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	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`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	A202046-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202046-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202046-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202046-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202046-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202046-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202046-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202046-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202046-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202046-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202046-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202046-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202046-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202046-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202046-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202046-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202046-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202046-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202046-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202046-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202046-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202046-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202046-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202046-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202046-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202046-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202046-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202046-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202046-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202046-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202046-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202046-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202046-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202046-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202046-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202046-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202046-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202046-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202046-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202046-001	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Micro Labs Limited	717eb542-3a05-485e-be76-3930efb40d33	2025-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202046 application number: ANDA202046 ndc (product): 42571-122
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Bryant Ranch Prepack	e885f084-9ce2-4e0c-aadb-c9d651224e5b	2025-06-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202046 application number: ANDA202046 ndc (product): 71335-1305
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	97a67686-7e94-dd77-e053-2995a90a42c6	2024-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202046 application number: ANDA202046 ndc (product): 68071-5107
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Proficient Rx LP	f10cfe9a-1884-4a65-b827-8fd781fb75c4	2020-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202046 application number: ANDA202046 ndc (product): 71205-210
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Marlex Pharmaceuticals Inc	f5d8d6a6-6455-430b-8923-090e1ca2ae3b	2018-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202046 application number: ANDA202046 ndc (product): 10135-639

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10135-639	Levocetirizine Dihydrochloride	levocetirizine Dihydrochloride	Marlex Pharmaceuticals Inc	ANDA	Current
42571-122	Levocetirizine Dihydrochloride	levocetirizine Dihydrochloride	Micro Labs Limited	ANDA	Current
42571-122	Levocetirizine Dihydrochloride	levocetirizine Dihydrochloride	Micro Labs Limited	ANDA	Current
42571-122	Levocetirizine Dihydrochloride	levocetirizine Dihydrochloride	Micro Labs Limited	ANDA	Current
42571-122	Levocetirizine Dihydrochloride	levocetirizine Dihydrochloride	Micro Labs Limited	ANDA	Current
68071-5107	Levocetirizine Dihydrochloride	levocetirizine Dihydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5107	Levocetirizine Dihydrochloride	levocetirizine Dihydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7699	Levocetirizine Dihydrochloride	levocetirizine Dihydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7699	Levocetirizine Dihydrochloride	levocetirizine Dihydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7699	Levocetirizine Dihydrochloride	levocetirizine Dihydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-2797	Levocetirizine Dihydrochloride	levocetirizine Dihydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2797	Levocetirizine Dihydrochloride	levocetirizine Dihydrochloride	REMEDYREPACK INC.	ANDA	Current
71205-210	Levocetirizine Dihydrochloride	levocetirizine Dihydrochloride	Proficient Rx LP	ANDA	Current
71205-210	Levocetirizine Dihydrochloride	levocetirizine Dihydrochloride	Proficient Rx LP	ANDA	Current
71205-210	Levocetirizine Dihydrochloride	levocetirizine Dihydrochloride	Proficient Rx LP	ANDA	Current
71335-1305	Levocetirizine Dihydrochloride	levocetirizine Dihydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1305	Levocetirizine Dihydrochloride	levocetirizine Dihydrochloride	Bryant Ranch Prepack	ANDA	Current