Donepezil Hydrochloride

ANDA 76786, held by Sun Pharm Inds Ltd. Donepezil Hydrochloride.

As of Nov 15, 2026, ANDA 76786 (Donepezil Hydrochloride), held by Sun Pharm Inds Ltd, was first approved by FDA on Nov 26, 2010, with 3 approved supplements and 0 published complete response letters.

First approved: Nov 26, 2010
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Nov 26, 2010	Original application	Approved	Letter

Products

2 strengths and forms


Donepezil Hydrochloride5MG · tablet;oral	Donepezil Hydrochloride	Discontinued
Donepezil Hydrochloride10MG · tablet;oral	Donepezil Hydrochloride	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Aug 14, 2014	Supplement 6Labeling · Standard review	Approved	None posted
Feb 16, 2011	Supplement 1Labeling	Approved	None posted
Feb 16, 2011	Supplement 2Labeling	Approved	None posted
Nov 26, 2010	Original application	Approved	Letter

Identifiers

Application: ANDA 76786
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters