Donepezil Hydrochloride

ANDA 77975, held by Sun Pharm Industries. Donepezil Hydrochloride.

As of Nov 15, 2026, ANDA 77975 (Donepezil Hydrochloride), held by Sun Pharm Industries, was first approved by FDA on Dec 11, 2009, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 11, 2009
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Dec 11, 2009	Original application	Approved	Label Letter

Products

2 strengths and forms


Donepezil Hydrochloride10MG · tablet, orally disintegrating;oral	Donepezil Hydrochloride	Discontinued
Donepezil Hydrochloride5MG · tablet, orally disintegrating;oral	Donepezil Hydrochloride	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Feb 16, 2011	Supplement 1Labeling	Approved	None posted
Feb 16, 2011	Supplement 2Labeling	Approved	None posted
Dec 11, 2009	Original application	Approved	Label Letter

Identifiers

Application: ANDA 77975
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