Amantadine Hydrochloride

Treats infection caused by various strains of influenza A virus. ANDA 71293, held by Sandoz. Amantadine Hydrochloride.

As of Nov 15, 2026, ANDA 71293 (Amantadine Hydrochloride), held by Sandoz, was first approved by FDA on Feb 18, 1987, with 26 approved supplements and 0 published complete response letters.

First approved: Feb 18, 1987
Supplements approved: 26
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Amantadine hydrochloride capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules, USP are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis Amantadine hydrochloride capsules, USP are 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 27 submissions below

Date	Submission	Status	Documents
Feb 18, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Amantadine Hydrochloride100MG · capsule;oral	Amantadine Hydrochloride	Rx

All 27 submissions, including labeling and manufacturing supplements


Jul 10, 2025	Supplement 44Labeling · Standard review	Approved	None posted
Sep 11, 2019	Supplement 40Manufacturing	Approved	None posted
Sep 11, 2019	Supplement 38Labeling · Standard review	Approved	None posted
Mar 25, 2009	Supplement 31Labeling	Approved	None posted
Nov 20, 2008	Supplement 29Labeling	Approved	None posted
Apr 1, 2008	Supplement 28Labeling	Approved	None posted
May 11, 2004	Supplement 21Labeling	Approved	None posted
Nov 8, 2002	Supplement 20Manufacturing	Approved	None posted
Nov 8, 2002	Supplement 19Manufacturing	Approved	None posted
Nov 8, 2002	Supplement 18Manufacturing	Approved	None posted
Nov 8, 2002	Supplement 17Manufacturing	Approved	None posted
Feb 7, 2002	Supplement 16Manufacturing	Approved	None posted
Feb 7, 2002	Supplement 15Manufacturing	Approved	None posted
Oct 17, 1997	Supplement 14Manufacturing	Approved	None posted
Jan 7, 1997	Supplement 12Manufacturing	Approved	None posted
Jan 25, 1996	Supplement 11Manufacturing	Approved	None posted
Jan 25, 1996	Supplement 10Manufacturing	Approved	None posted
Jan 25, 1996	Supplement 9Manufacturing	Approved	None posted
Jan 25, 1996	Supplement 8Manufacturing	Approved	None posted
Jan 25, 1996	Supplement 7Labeling	Approved	None posted
Jan 25, 1996	Supplement 6Manufacturing	Approved	None posted
Sep 28, 1994	Supplement 5Labeling	Approved	None posted
Sep 11, 1991	Supplement 4Labeling	Approved	None posted
Jun 27, 1991	Supplement 3Manufacturing	Approved	None posted
Jul 14, 1989	Supplement 2Labeling	Approved	None posted
Mar 30, 1988	Supplement 1Manufacturing	Approved	None posted
Feb 18, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 71293
Drugs@FDA: Overview at FDA
Company: Sandoz

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