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 1 of 3 · 47 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DonepezilDONEPEZIL HYDROCHLORIDEREMEDYREPACK INC.37fc6638-4a63-4582-a64c-3525f8ed7ef22026-09-09Warnings, Adverse reactionsName fallback
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEREMEDYREPACK INC.de96349a-5fee-4de9-921c-e453d44b32032026-09-09Warnings, Adverse reactionsName fallback
brand name: Donepezil Hydrochloride
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEA-S Medication Solutions0516d548-db9b-410a-aec9-79aedbc3f6e92026-08-18Warnings, Adverse reactionsName fallback
brand name: Donepezil Hydrochloride
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEGolden State Medical Supply, Inc.a085ed33-c262-44ab-e053-2a95a90a55572026-05-27Warnings, Adverse reactionsName fallback
brand name: Donepezil Hydrochloride
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEUpsher-Smith Laboratories, LLC12a755c5-1ad9-43d1-832a-eb2ff17bd6932026-05-08Warnings, Adverse reactionsName fallback
brand name: Donepezil Hydrochloride
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDECardinal Health 107, LLCc942a4c9-dbe5-4131-bb6c-aa2d31b387e72026-04-24Warnings, Adverse reactionsName fallback
brand name: Donepezil Hydrochloride
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEPreferred Pharmaceuticals Inc.ee54a472-6783-41df-b8bb-9c3e4c9969072026-04-08Warnings, Adverse reactionsName fallback
brand name: Donepezil Hydrochloride
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEPreferred Pharmaceuticals Inc.8138f616-83f3-4c47-84ef-1bce2db339f72026-04-08Warnings, Adverse reactionsName fallback
brand name: Donepezil Hydrochloride
generic name: DONEPEZIL HYDROCHLORIDE
donepezil hydrochlorideDONEPEZIL HYDROCHLORIDEREMEDYREPACK INC.41c095b6-acd9-4627-a813-bbca7ecafee52026-03-30Warnings, Adverse reactionsName fallback
brand name: donepezil hydrochloride
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEGolden State Medical Supply, Inc.56abe961-ec94-4a77-b548-426f6255539e2026-03-09Warnings, Adverse reactionsName fallback
brand name: Donepezil Hydrochloride
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEMajor Pharmaceuticalsc777ddc9-0b61-4d6f-95d6-818ba1861d622026-02-19Warnings, Adverse reactionsName fallback
brand name: Donepezil Hydrochloride
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDETorrent Pharmaceuticals Limited76bf638e-dbde-418e-8977-1caf009990bc2026-02-05Warnings, Adverse reactionsName fallback
brand name: Donepezil Hydrochloride
generic name: DONEPEZIL HYDROCHLORIDE
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEScieGen Pharmaceuticals, Inc.6e9aacf9-abb6-4dec-9a8d-4eabf934d5122026-01-30Warnings, Adverse reactionsName fallback
brand name: Donepezil Hydrochloride
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
brand name: donepezil hydrochloride
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
brand name: Donepezil hydrochloride
generic name: DONEPEZIL HYDROCHLORIDE
donepezil hydrochlorideDONEPEZIL HYDROCHLORIDESolco Healthcare US, LLC48178cb4-4fee-47c0-88e9-a4f017f1f4482025-06-30Warnings, Adverse reactionsName fallback
brand name: donepezil hydrochloride
generic name: DONEPEZIL HYDROCHLORIDE
donepezil hydrochlorideDONEPEZIL HYDROCHLORIDESolco Healthcare US, LLC042a59ea-131a-4806-b0f4-2f791d4414e22025-06-30Warnings, 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.