Home Applications 085985 Application 085985
Type ANDA
Sponsor NEXGEN PHARMA INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DIMENHYDRINATE DIMENHYDRINATE TABLET;ORAL 50MG 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 A085985-001 DIMENHYDRINATE DIMENHYDRINATE 50MG TABLET / 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 · 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 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A085985-001 DIMENHYDRINATE 50MG TABLET / ORAL Approved before 1982 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 2 · 32 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Motion Sickness Relief DIMENHYDRINATE Walgreen Company ace7eba4-e033-48f5-8533-c3ea9dfc32b0 2026-08-12 Warnings Name fallback generic name: DIMENHYDRINATE Motion Sickness Relief DIMENHYDRINATE Cardinal Health 110, LLC. DBA Leader ce83a868-bdd8-4c77-9bc0-664133028f75 2026-08-06 Warnings Name fallback generic name: DIMENHYDRINATE Motion Sickness Relief DIMENHYDRINATE Chain Drug Marketing Association, Inc. 00a327c6-6b86-4702-8c04-55c405c1404c 2026-07-23 Warnings Name fallback generic name: DIMENHYDRINATE Motion Sickness DIMENHYDRINATE CVS Pharmacy 0998947c-cfba-497e-bf7a-9c7f8fff1764 2026-07-16 Warnings Name fallback generic name: DIMENHYDRINATE Motion Sickness Relief DIMENHYDRINATE L.N.K. International, Inc. 95aae32f-6b3f-469d-86a5-c201a53f862a 2026-06-29 Warnings Name fallback generic name: DIMENHYDRINATE Motion Sickness Relief DIMENHYDRINATE Wal-Mart Stores Inc c25a7f2b-0f01-4ec0-8849-f08c23608d1d 2026-06-22 Warnings Name fallback generic name: DIMENHYDRINATE Motion Sickness Relief DIMENHYDRINATE Topco Associates, LLC 503a70db-d564-4ea0-851e-8ff617e70728 2026-06-16 Warnings Name fallback generic name: DIMENHYDRINATE Motion Sickness DIMENHYDRINATE Geiss, Destin & Dunn Inc. fdb683c5-ff7f-4b93-9892-670cf1f29f2a 2026-06-15 Warnings Name fallback generic name: DIMENHYDRINATE Dimenhydrinate DIMENHYDRINATE CVS Pharmacy, Inc. 6dfc5cb4-af0c-56c9-e053-2a91aa0a5d56 2026-06-12 Warnings Name fallback brand name: Dimenhydrinate generic name: DIMENHYDRINATE Driminate DIMENHYDRINATE Major Pharmaceuticals d2967f78-41ee-4c30-8b47-0757df9f3d91 2026-06-10 Warnings Name fallback generic name: DIMENHYDRINATE Motion Sickness Relief DIMENHYDRINATE Amerisource Bergen c4077301-db6c-473d-beb3-232d7134a13a 2026-06-03 Warnings Name fallback generic name: DIMENHYDRINATE Motion Sickness Relief DIMENHYDRINATE Valu Merchandisers Company 56c26102-8d39-458e-b076-3fe67456a4c0 2026-04-16 Warnings Name fallback generic name: DIMENHYDRINATE Motion Sickness DIMENHYDRINATE Strategic Sourcing Services LLC be8f91d4-6e4f-4d47-93e9-7fb91160b7df 2026-04-02 Warnings Name fallback generic name: DIMENHYDRINATE Motion Sickness DIMENHYDRINATE Target Corporation 3fd4a96f-8f69-42bf-b777-6e3a2bfea275 2026-03-03 Warnings Name fallback generic name: DIMENHYDRINATE Dimenhydrinate DIMENHYDRINATE LEADER/ Cardinal Health 110, Inc. 7c4adbdb-9bce-0c9c-e053-2a91aa0a8107 2026-02-20 Warnings Name fallback brand name: Dimenhydrinate generic name: DIMENHYDRINATE Motion Sickness Relief DIMENHYDRINATE Rite Aid Corporation 4f532984-aeee-4dde-972c-742bdf12868f 2026-01-07 Warnings Name fallback generic name: DIMENHYDRINATE Dramamine Original Formula DIMENHYDRINATE Medtech Products Inc. f9302a5a-295a-4501-9332-e3f5eb387362 2025-10-23 Warnings Name fallback generic name: DIMENHYDRINATE Motion Sickness Relief DIMENHYDRINATE WinCo Foods, LLC be8b1af8-bf84-4de5-afc7-a04d420d918f 2025-09-23 Warnings Name fallback generic name: DIMENHYDRINATE Dramamine for Kids DIMENHYDRINATE Medtech Products Inc. 12bc3f17-ed62-4d0d-9b1e-3835579e711b 2025-09-10 Warnings Name fallback generic name: DIMENHYDRINATE Dramamine Orange DIMENHYDRINATE Medtech Products Inc. 76166156-bce1-492f-833e-6bbd07859c3f 2025-09-10 Warnings Name fallback generic name: DIMENHYDRINATE