Amantadine Hydrochloride

ANDA 209221, held by Chartwell Molecular. Amantadine Hydrochloride.

As of Nov 15, 2026, ANDA 209221 (Amantadine Hydrochloride), held by Chartwell Molecular, was first approved by FDA on Jun 15, 2017, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 15, 2017
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jun 15, 2017	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Jul 10, 2025	Supplement 5Labeling · Standard review	Approved	None posted
Jun 15, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 209221
Drugs@FDA: Overview at FDA
Company: Chartwell Molecular

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