Amantadine Hydrochloride

Treats infection caused by various strains of influenza A virus. ANDA 74509, held by Pharm Assoc. Amantadine Hydrochloride.

As of Nov 15, 2026, ANDA 74509 (Amantadine Hydrochloride), held by Pharm Assoc, was first approved by FDA on Jul 17, 1995, with 12 approved supplements and 0 published complete response letters.

First approved: Jul 17, 1995
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 USP is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride is also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis Amantadine hydrochloride 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
Jul 17, 1995	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 19Labeling · Standard review	Approved	None posted
Jun 5, 2012	Supplement 12Labeling	Approved	None posted
Sep 26, 2011	Supplement 11Labeling	Approved	None posted
Dec 7, 2009	Supplement 10Labeling	Approved	None posted
Apr 29, 2009	Supplement 9Labeling	Approved	None posted
Feb 19, 2009	Supplement 8Labeling	Approved	None posted
Sep 3, 2008	Supplement 7Labeling	Approved	None posted
Sep 14, 2007	Supplement 6Labeling	Approved	None posted
May 1, 2006	Supplement 4Labeling	Approved	None posted
Sep 18, 2002	Supplement 3Labeling	Approved	None posted
Jul 20, 1999	Supplement 2Manufacturing	Approved	None posted
Jul 20, 1999	Supplement 1Manufacturing	Approved	None posted
Jul 17, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 74509
Drugs@FDA: Overview at FDA
Company: Pharmaceutical Associates

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