Application 084092

Type: ANDA
Sponsor: INVATECH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
003	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A084092-003	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA		1989-05-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A084092-003	AA

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 · 43 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
2026-09-14 22:38:34	2026-08	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084092-003	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	1989-05-22	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A084092-003	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A084092-003	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084092-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084092-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084092-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084092-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084092-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084092-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084092-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084092-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084092-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084092-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084092-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084092-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084092-003	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084092-003	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084092-003	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084092-003	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084092-003	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084092-003	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084092-003	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084092-003	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084092-003	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084092-003	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084092-003	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084092-003	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084092-003	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084092-003	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084092-003	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084092-003	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084092-003	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084092-003	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084092-003	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084092-003	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084092-003	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084092-003	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084092-003	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084092-003	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084092-003	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084092-003	AA	1	`f41ea6bd6efb…`

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 5 of 5 · 85 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCLORIDE	Proficient Rx LP	f574e123-8db7-4e3d-a0ee-e4e1f04ff146	2022-06-01	Warnings, Adverse reactions	Name fallback brand name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Proficient Rx LP	91b1fd1a-1da2-4aae-826f-7de0bfe62161	2021-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCLORIDE	Asclemed USA, Inc.	5c70e61b-a1e6-4981-92e2-1050cee08baa	2020-10-30	Warnings, Adverse reactions	Name fallback brand name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Epic Pharma LLC	467e464b-bbaf-4053-9136-39e47a92fa05	2020-08-21	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	Bryant Ranch Prepack	53f410fd-104c-42c1-9740-6f48ffbc974f	2020-05-22	Warnings, Adverse reactions	Name fallback brand name: MECLIZINE HYDROCHLORIDE generic name: MECLIZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.