Application 076893

Type
ANDA
Sponsor
PAR PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDETABLET; ORAL5MGNoNo
002DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDETABLET; ORAL10MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 2 of 3 · 47 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEBryant Ranch Prepacke2ab403a-ec2d-44e7-9da1-66d0a7443f1d2025-06-05Warnings, Adverse reactionsName fallback
brand name: Donepezil Hydrochloride
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil hydrochlorideDONEPEZIL HYDROCHLORIDEDr. Reddys Laboratories Limited7c0d3bcb-157d-0414-64ee-055bc614d1902025-04-11Warnings, Adverse reactionsName fallback
brand name: Donepezil hydrochloride
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDECoupler LLC2d01fb96-c825-fad5-e063-6394a90ac6cc2025-01-31Warnings, Adverse reactionsName fallback
brand name: Donepezil Hydrochloride
generic name: DONEPEZIL HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDEDirect_Rx93dddf28-094b-dd8c-e053-2995a90a63e92025-01-22Warnings, Adverse reactionsName fallback
brand name: DONEPEZIL HYDROCHLORIDE
generic name: DONEPEZIL HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDEDirectRxcb1b3ed1-6e68-08e2-e053-2995a90a68c42025-01-20Warnings, Adverse reactionsName fallback
brand name: DONEPEZIL HYDROCHLORIDE
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs7620f41a-3eef-453b-a564-ea3c85374de22025-01-08Warnings, Adverse reactionsName fallback
brand name: Donepezil Hydrochloride
generic name: DONEPEZIL HYDROCHLORIDE
DonepezilDONEPEZIL HYDROCHLORIDECamber Pharmaceuticals, Inc.11ac01f4-d26e-47b2-9660-d514ab097fdb2025-01-07Warnings, Adverse reactionsName fallback
generic name: DONEPEZIL HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDELupin Pharmaceuticals, Inc.03e26183-3e07-45e8-a414-a8bad32483e22024-11-29Warnings, Adverse reactionsName fallback
brand name: DONEPEZIL HYDROCHLORIDE
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsac857917-74db-4591-be9f-d1c822c68c812024-07-18Warnings, Adverse reactionsName fallback
brand name: Donepezil Hydrochloride
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEBryant Ranch Prepackc030fd7c-da5c-457a-a825-1767bd87d04d2024-04-03Warnings, Adverse reactionsName fallback
brand name: Donepezil Hydrochloride
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEBryant Ranch Prepack4747633b-ac32-455e-8d50-ce9c481480c02024-04-03Warnings, Adverse reactionsName fallback
brand name: Donepezil Hydrochloride
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEBryant Ranch Prepackaa2c22b8-2dd4-4916-bc4f-9995eab74a6e2024-04-03Warnings, Adverse reactionsName fallback
brand name: Donepezil Hydrochloride
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEBryant Ranch Prepack1c6e8d7f-5219-4b6c-a1ce-2baff28c3d552024-02-06Warnings, Adverse reactionsName fallback
brand name: Donepezil Hydrochloride
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEBryant Ranch Prepack8090bff0-e0f0-4846-a2ab-cb28a0a2648d2024-02-05Warnings, Adverse reactionsName fallback
brand name: Donepezil Hydrochloride
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEBryant Ranch Prepackcaebc31c-5a35-4434-b7e2-80f6405383ca2024-01-11Warnings, Adverse reactionsName fallback
brand name: Donepezil Hydrochloride
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEAurobindo Pharma Limited3257494f-8f44-4978-b92d-bde87b2444b62024-01-08Warnings, Adverse reactionsName fallback
brand name: Donepezil Hydrochloride
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDERising Pharma Holdings, Inc.86b0c5a0-ff3c-4840-a4ac-82af922d58bf2024-01-08Warnings, Adverse reactionsName fallback
brand name: Donepezil Hydrochloride
generic name: DONEPEZIL HYDROCHLORIDE
donepezil hydrochlorideDONEPEZIL HYDROCHLORIDEBryant Ranch Prepackc26d9bf3-e148-48bb-8f4f-e8c73804b3112023-11-17Warnings, Adverse reactionsName fallback
brand name: donepezil hydrochloride
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEMacleods Pharmaceuticals Limited06dd25a5-1bf2-446d-ad75-ff9d551176602023-08-11Warnings, Adverse reactionsName fallback
brand name: Donepezil Hydrochloride
generic name: DONEPEZIL HYDROCHLORIDE
donepezil hydrochlorideDONEPEZIL HYDROCHLORIDEA-S Medication Solutions5d46ef3c-0dee-4389-a2d5-997ea83428172023-02-06Warnings, Adverse reactionsName fallback
brand name: donepezil hydrochloride
generic name: DONEPEZIL HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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