Amantadine Hydrochloride

ANDA 76352, held by Chartwell Rx. Amantadine Hydrochloride.

As of Nov 15, 2026, ANDA 76352 (Amantadine Hydrochloride), held by Chartwell Rx, was first approved by FDA on Sep 10, 2004, with 2 approved supplements and 0 published complete response letters.

First approved: Sep 10, 2004
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
Sep 10, 2004	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Amantadine Hydrochloride50MG/5ML · syrup;oral	Amantadine Hydrochloride	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Jul 10, 2025	Supplement 3Labeling · Standard review	Approved	None posted
Aug 1, 2011	Supplement 1Labeling	Approved	None posted
Sep 10, 2004	Original application	Approved	None posted

Identifiers

Application: ANDA 76352
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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