Amantadine Hydrochloride

ANDA 212407, held by Adaptis. Amantadine Hydrochloride.

As of Nov 15, 2026, ANDA 212407 (Amantadine Hydrochloride), held by Adaptis, was first approved by FDA on May 27, 2022, with 1 approved supplement and 0 published complete response letters.

First approved: May 27, 2022
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
May 27, 2022	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Jul 10, 2025	Supplement 1Labeling · Standard review	Approved	None posted
May 27, 2022	Original application	Approved	None posted

Identifiers

Application: ANDA 212407
Drugs@FDA: Overview at FDA
Company: Adaptis

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