Amantadine Hydrochloride

ANDA 74170, held by Aurobindo Pharma USA. Amantadine Hydrochloride.

As of Nov 15, 2026, ANDA 74170 (Amantadine Hydrochloride), held by Aurobindo Pharma USA, was first approved by FDA on Oct 28, 1994, with 4 approved supplements and 0 published complete response letters.

First approved: Oct 28, 1994
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Oct 28, 1994	Original application	Approved	None posted

Products

1 strengths and forms

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

All 5 submissions, including labeling and manufacturing supplements


Jul 10, 2025	Supplement 11Labeling · Standard review	Approved	None posted
Jun 4, 2014	Supplement 3Manufacturing	Approved	None posted
Jun 17, 2011	Supplement 2Labeling	Approved	None posted
Sep 18, 2009	Supplement 1Labeling	Approved	None posted
Oct 28, 1994	Original application	Approved	None posted

Identifiers

Application: ANDA 74170
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma USA

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