FDA.reportPublic FDA data

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 3 of 3 · 47 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEAlembic Pharmaceuticals Limitedbc570682-413b-46fb-a069-c2986884bfce2023-01-27Warnings, Adverse reactionsName fallback
brand name: Donepezil Hydrochloride
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEA-S Medication Solutions0c6b12e8-1933-40d8-bf43-97339b2b54fb2023-01-18Warnings, Adverse reactionsName fallback
brand name: Donepezil Hydrochloride
generic name: DONEPEZIL HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDECadila Pharmaceuticals Limited37aa1285-774a-4714-a4af-4e3fa9fa7f552022-12-27Warnings, Adverse reactionsName fallback
brand name: DONEPEZIL HYDROCHLORIDE
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEProficient Rx LP32709bda-53d0-4d57-9f0b-3e1f28e39f252022-04-01Warnings, Adverse reactionsName fallback
brand name: Donepezil Hydrochloride
generic name: DONEPEZIL HYDROCHLORIDE
AriceptDONEPEZIL HYDROCHLORIDEEisai Inc.98e451e1-e4d7-4439-a675-c5457ba209752021-12-30Warnings, Adverse reactionsName fallback
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEAlembic Pharmaceuticals Inc.9407258b-60ed-4884-a903-885aeedaddf82021-10-11Warnings, Adverse reactionsName fallback
brand name: Donepezil Hydrochloride
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDESun Pharmaceutical Industries, Inc.79ad107b-bb20-4ed3-89f0-d7c862f3957c2018-10-31Warnings, 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.