Amantadine Hydrochloride

Treats infection caused by various strains of influenza A virus. ANDA 74028, held by Chartwell Rx. Amantadine Hydrochloride.

As of Nov 15, 2026, ANDA 74028 (Amantadine Hydrochloride), held by Chartwell Rx, was first approved by FDA on Jun 28, 1993, with 12 approved supplements and 0 published complete response letters.

First approved: Jun 28, 1993
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Amantadine hydrochloride oral solution is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride oral solution is also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis Amantadine hydrochloride oral solution is indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Jun 28, 1993	Original application	Approved	None posted

Products

1 strengths and forms

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

All 13 submissions, including labeling and manufacturing supplements


Jul 10, 2025	Supplement 18Labeling · Standard review	Approved	None posted
Jan 18, 2012	Supplement 17Labeling	Approved	None posted
Mar 22, 2006	Supplement 12Labeling	Approved	None posted
Aug 13, 2002	Supplement 9Manufacturing	Approved	None posted
Jul 31, 1998	Supplement 8Manufacturing	Approved	None posted
Feb 4, 1998	Supplement 7Manufacturing	Approved	None posted
Feb 4, 1998	Supplement 6Manufacturing	Approved	None posted
Sep 12, 1997	Supplement 5Manufacturing	Approved	None posted
Jan 25, 1996	Supplement 3Manufacturing	Approved	None posted
Dec 22, 1995	Supplement 4Labeling	Approved	None posted
Jun 12, 1995	Supplement 2Manufacturing	Approved	None posted
Sep 27, 1994	Supplement 1Labeling	Approved	None posted
Jun 28, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 74028
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