Amantadine Hydrochloride, Amantadine

ANDA 214897, held by Zydus. Amantadine Hydrochloride, Amantadine.

As of Nov 15, 2026, ANDA 214897 (Amantadine Hydrochloride, Amantadine), held by Zydus, was first approved by FDA on Aug 26, 2024, with 1 approved supplement and 0 published complete response letters.

First approved: Aug 26, 2024
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

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


Aug 26, 2024	Original application	Approved	Letter
Aug 26, 2024	Original application	Tentative approval	None posted

Products

2 strengths and forms


Amantadine HydrochlorideEQ 68.5MG BASE · capsule, extended release;oral	Amantadine Hydrochloride	Discontinued
Amantadine137MG · capsule, extended release;oral	Amantadine	None (tentative approval)

All 3 submissions, including labeling and manufacturing supplements


Aug 17, 2026	Supplement 1Labeling · Standard review	Approved	None posted
Aug 26, 2024	Original application	Approved	Letter
Aug 26, 2024	Original application	Tentative approval	None posted

Identifiers

Application: ANDA 214897
Drugs@FDA: Overview at FDA
Company: Zydus

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