FDA.reportPublic FDA data

Application 021719

Type
NDA
Sponsor
EISAI INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARICEPTDONEPEZIL HYDROCHLORIDESOLUTION;ORAL5MG/5MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021719-001ARICEPTDONEPEZIL HYDROCHLORIDE5MG/5MLSOLUTION / ORALRLD2004-10-18

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021719-001ARICEPT5MG/5MLSOLUTION / ORALRLD2004-10-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021719-001ARICEPT5MG/5MLSOLUTION / ORALRLD2004-10-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N021719-001ARICEPT5MG/5MLSOLUTION / ORALRLD2004-10-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021719-001ARICEPT5MG/5MLSOLUTION / ORALRLD2004-10-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021719-001ARICEPT5MG/5MLSOLUTION / ORALRLD2004-10-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021719-001ARICEPT5MG/5MLSOLUTION / ORALRLD2004-10-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021719-001ARICEPT5MG/5MLSOLUTION / ORALRLD2004-10-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021719-001ARICEPT5MG/5MLSOLUTION / ORALRLD2004-10-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021719-001ARICEPT5MG/5MLSOLUTION / ORALRLD2004-10-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021719-001ARICEPT5MG/5MLSOLUTION / ORALRLD2004-10-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021719-001ARICEPT5MG/5MLSOLUTION / ORALRLD2004-10-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021719-001ARICEPT5MG/5MLSOLUTION / ORALRLD2004-10-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021719-001ARICEPT5MG/5MLSOLUTION / ORALRLD2004-10-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021719-001ARICEPT5MG/5MLSOLUTION / ORALRLD2004-10-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021719-001ARICEPT5MG/5MLSOLUTION / ORAL2004-10-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021719-001ARICEPT5MG/5MLSOLUTION / ORAL2004-10-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021719-001ARICEPT5MG/5MLSOLUTION / ORAL2004-10-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021719-001ARICEPT5MG/5MLSOLUTION / ORAL2004-10-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021719-001ARICEPT5MG/5MLSOLUTION / ORAL2004-10-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021719-001ARICEPT5MG/5MLSOLUTION / ORAL2004-10-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021719-001ARICEPT5MG/5MLSOLUTION / ORAL2004-10-1887673890dc5c…
2021-03-12 10:30 UTC2021-03N021719-001ARICEPT5MG/5MLSOLUTION / ORAL2004-10-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021719-001ARICEPT5MG/5MLSOLUTION / ORAL2004-10-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021719-001ARICEPT5MG/5MLSOLUTION / ORAL2004-10-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021719-001ARICEPT5MG/5MLSOLUTION / ORAL2004-10-183f01610625f2…
2019-09-15 20:21 UTC2019-09N021719-001ARICEPT5MG/5MLSOLUTION / ORAL2004-10-18b00525d2431f…
2019-07-19 19:46 UTC2019-07N021719-001ARICEPT5MG/5MLSOLUTION / ORAL2004-10-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021719-001ARICEPT5MG/5MLSOLUTION / ORALRLD2004-10-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021719-001ARICEPT5MG/5MLSOLUTION / ORALRLD2004-10-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021719-001ARICEPT5MG/5MLSOLUTION / ORALRLD2004-10-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021719-001ARICEPT5MG/5MLSOLUTION / ORALRLD2004-10-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021719-001ARICEPT5MG/5MLSOLUTION / ORALRLD2004-10-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021719-001ARICEPT5MG/5MLSOLUTION / ORALRLD2004-10-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021719-001ARICEPT5MG/5MLSOLUTION / ORAL2004-10-183f0d92c62455…
2023-05-13 08:27 UTC2023-05N021719-001ARICEPT5MG/5MLSOLUTION / ORAL2004-10-18053a50430f4f…
2023-01-26 05:58 UTC2023-01N021719-001ARICEPT5MG/5MLSOLUTION / ORAL2004-10-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021719-001ARICEPT5MG/5MLSOLUTION / ORAL2004-10-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021719-001ARICEPT5MG/5MLSOLUTION / ORAL2004-10-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021719-001ARICEPT5MG/5MLSOLUTION / ORAL2004-10-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021719-001ARICEPT5MG/5MLSOLUTION / ORAL2004-10-18cb3db0bc1861…

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 3 · 52 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEGolden State Medical Supply, Inc.a085ed33-c262-44ab-e053-2a95a90a55572026-05-27Warnings, Adverse reactionsName fallback
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEUpsher-Smith Laboratories, LLC12a755c5-1ad9-43d1-832a-eb2ff17bd6932026-05-08Warnings, Adverse reactionsName fallback
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDECardinal Health 107, LLCc942a4c9-dbe5-4131-bb6c-aa2d31b387e72026-04-24Warnings, Adverse reactionsName fallback
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEPreferred Pharmaceuticals Inc.ee54a472-6783-41df-b8bb-9c3e4c9969072026-04-08Warnings, Adverse reactionsName fallback
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEPreferred Pharmaceuticals Inc.8138f616-83f3-4c47-84ef-1bce2db339f72026-04-08Warnings, Adverse reactionsName fallback
generic name: DONEPEZIL HYDROCHLORIDE
donepezil hydrochlorideDONEPEZIL HYDROCHLORIDEREMEDYREPACK INC.41c095b6-acd9-4627-a813-bbca7ecafee52026-03-30Warnings, Adverse reactionsName fallback
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEGolden State Medical Supply, Inc.56abe961-ec94-4a77-b548-426f6255539e2026-03-09Warnings, Adverse reactionsName fallback
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEMajor Pharmaceuticalsc777ddc9-0b61-4d6f-95d6-818ba1861d622026-02-19Warnings, Adverse reactionsName fallback
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDETorrent Pharmaceuticals Limited76bf638e-dbde-418e-8977-1caf009990bc2026-02-05Warnings, Adverse reactionsName fallback
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEScieGen Pharmaceuticals, Inc.6e9aacf9-abb6-4dec-9a8d-4eabf934d5122026-01-30Warnings, Adverse reactionsName fallback
generic name: DONEPEZIL HYDROCHLORIDE
DonepezilDONEPEZIL HYDROCHLORIDEA-S Medication Solutions84d8ca68-26f3-4dd5-9dd4-6a7525a30db12026-01-20Warnings, Adverse reactionsName fallback
generic name: DONEPEZIL HYDROCHLORIDE
donepezil hydrochlorideDONEPEZIL HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.1a8906ce-96dc-4bc8-81c1-5db67a187aac2025-12-19Warnings, Adverse reactionsName fallback
generic name: DONEPEZIL HYDROCHLORIDE
DonepezilDONEPEZIL HYDROCHLORIDEQuallent Pharmaceuticals Health LLCc7e1f642-1bdc-4ed6-9b9e-c1af40b926cd2025-12-05Warnings, Adverse reactionsName fallback
generic name: DONEPEZIL HYDROCHLORIDE
DonepezilDONEPEZIL HYDROCHLORIDEAmerican Health Packaging12ae85f0-023c-49ca-8c4a-0a6a7585290e2025-09-24Warnings, Adverse reactionsName fallback
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil hydrochlorideDONEPEZIL HYDROCHLORIDEEdenbridge Pharmaceuticals LLC.11404dc3-1bde-4d4e-8386-006b67ee19dd2025-08-01Warnings, Adverse reactionsName fallback
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEREMEDYREPACK INC.de96349a-5fee-4de9-921c-e453d44b32032025-07-16Warnings, Adverse reactionsName fallback
generic name: DONEPEZIL HYDROCHLORIDE
DonepezilDONEPEZIL HYDROCHLORIDEREMEDYREPACK INC.37fc6638-4a63-4582-a64c-3525f8ed7ef22025-07-02Warnings, Adverse reactionsName fallback
generic name: DONEPEZIL HYDROCHLORIDE
donepezil hydrochlorideDONEPEZIL HYDROCHLORIDESolco Healthcare US, LLC48178cb4-4fee-47c0-88e9-a4f017f1f4482025-06-30Warnings, Adverse reactionsName fallback
generic name: DONEPEZIL HYDROCHLORIDE
donepezil hydrochlorideDONEPEZIL HYDROCHLORIDESolco Healthcare US, LLC042a59ea-131a-4806-b0f4-2f791d4414e22025-06-30Warnings, Adverse reactionsName fallback
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEBryant Ranch Prepacke2ab403a-ec2d-44e7-9da1-66d0a7443f1d2025-06-05Warnings, Adverse reactionsName fallback
generic name: DONEPEZIL HYDROCHLORIDE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
6041SUPPL2006-10-23
37513SUPPL2006-10-18
28452ORIG2004-10-22
16251ORIG2004-10-22