Amantadine Hydrochloride

ANDA 77659, held by Actavis Elizabeth. Amantadine Hydrochloride.

As of Nov 15, 2026, ANDA 77659 (Amantadine Hydrochloride), held by Actavis Elizabeth, was first approved by FDA on Feb 23, 2006, with 2 approved supplements and 0 published complete response letters.

First approved: Feb 23, 2006
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
Feb 23, 2006	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Amantadine Hydrochloride100MG · capsule;oral	Amantadine Hydrochloride	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Jul 10, 2025	Supplement 3Labeling · Standard review	Approved	None posted
Nov 27, 2016	Supplement 2Labeling	Approved	None posted
Feb 23, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 77659
Drugs@FDA: Overview at FDA
Company: Actavis Elizabeth

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