Home Applications 086392 Application 086392
Type ANDA
Sponsor NEXGEN PHARMA INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET, CHEWABLE;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 A086392-001 MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982
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 RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 84e616aacf4f…2026-08-18 06:07:40 2026-07 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A086392-001 MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE / ORAL Approved before 1982 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 1 of 5 · 88 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE A-S Medication Solutions 2518b0b6-35ab-49f4-936c-1eafea04b466 2026-09-09 Warnings Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE Dramamine Less Drowsy MECLIZINE HYDROCHLORIDE Medtech Products Inc. fa6a0969-7427-4b87-bc04-a2792665c218 2026-09-04 Warnings Name fallback generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE REMEDYREPACK INC. 21d4a6ee-0a66-45d7-bab9-c5eef399713d 2026-09-01 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE 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 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