Home Applications 084092 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 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 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 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 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…2022-09-29 23:25 UTC 2022-09 A084092-003 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 1989-05-22 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 5 · 89 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE Coupler LLC 598eb392-1dfe-c08c-e063-6394a90a4c7d 2026-08-21 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE Bryant Ranch Prepack cd82fca9-a8dc-4545-8e64-b67d644832e7 2026-08-20 Warnings Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE REMEDYREPACK INC. 21d4a6ee-0a66-45d7-bab9-c5eef399713d 2026-08-17 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE MECLIZINE Preferred Pharmaceuticals Inc. f755f8f3-7645-433c-b502-c1f15b700299 2026-08-03 Warnings, Adverse reactions Name fallback brand name: MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE MECLIZINE Bryant Ranch Prepack dab43efd-bec6-472f-b13a-1c043914dcd1 2026-07-27 Warnings, Adverse reactions Name fallback brand name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE Rugby Laboratories b57f14a7-3852-03db-e053-2a95a90a80d6 2026-07-16 Warnings Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE Northwind Health Company, LLC 1b541252-e8a7-b678-e063-6394a90a34dc 2026-07-14 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCLORIDE REMEDYREPACK INC. ba2fb6de-af86-4c05-9018-135e1f8594f9 2026-07-03 Warnings, Adverse reactions Name fallback brand name: MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE MECLIZINE Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. b11c10b9-f40e-4ea7-9c5d-118517049f9d 2026-06-25 Warnings, Adverse reactions Name fallback brand name: MECLIZINE HYDROCHLORIDE DRAMAMINE CHEWABLE ORANGE MECLIZINE HYDROCHLORIDE Medtech Products Inc. 30387e63-278d-412a-bcad-7965c7c0aea7 2026-06-23 Warnings Name fallback generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE St. Mary's Medical Park Pharmacy c6b3f4d8-5fcf-2278-e053-2a95a90ab139 2026-06-21 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE Preferred Pharmaceuticals Inc. d7d31433-8f39-4fe6-b542-1b4410122db7 2026-06-12 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE Redpharm Drug 53df5b1b-64da-e805-e063-6294a90a0a55 2026-06-10 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE MECLIZINE Bryant Ranch Prepack 1079db3f-d8ad-4c25-aa91-8ac8054ee4f2 2026-06-08 Warnings, Adverse reactions Name fallback brand name: MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE MECLIZINE Redpharm Drug 52ee9258-8311-e6bd-e063-6294a90a567f 2026-05-29 Warnings, Adverse reactions Name fallback brand name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE Bryant Ranch Prepack 81e1762b-e012-4c6d-96e6-9a9f27a1880a 2026-05-27 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE Major Pharmaceuticals f99f13ab-33c0-4304-8dc5-3a75f3909377 2026-05-26 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE QPharma Inc 2df6edde-4479-ed9d-e063-6394a90abdc1 2026-05-11 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE MECLIZINE Redpharm Drug 4727e7a9-eabb-a2a7-e063-6394a90a8754 2026-05-05 Warnings, Adverse reactions Name fallback brand name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE REMEDYREPACK INC. d53bf04e-5cfc-4974-9b24-2cce545d1bd0 2026-04-15 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE