Amantadine Hydrochloride

Treats infection caused by various strains of influenza A virus. ANDA 70589, held by Upsher Smith Labs. Amantadine Hydrochloride.

As of Nov 15, 2026, ANDA 70589 (Amantadine Hydrochloride), held by Upsher Smith Labs, was first approved by FDA on Jan 7, 1987, with 29 approved supplements and 0 published complete response letters.

First approved: Jan 7, 1987
Supplements approved: 29
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Amantadine hydrochloride capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis: Amantadine hydrochloride capsules 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 30 submissions below

Date	Submission	Status	Documents
Jan 7, 1987	Original application	Approved	None posted

Products

1 strengths and forms

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

All 30 submissions, including labeling and manufacturing supplements


Jul 10, 2025	Supplement 54Labeling · Standard review	Approved	None posted
Jul 28, 2014	Supplement 44Manufacturing	Approved	None posted
Jan 11, 2012	Supplement 45Labeling	Approved	None posted
Jun 5, 2009	Supplement 40Labeling	Approved	None posted
Feb 9, 2009	Supplement 38Labeling	Approved	None posted
Nov 19, 2007	Supplement 37Labeling	Approved	None posted
Nov 17, 2004	Supplement 29Labeling	Approved	None posted
Oct 31, 2003	Supplement 26Labeling	Approved	None posted
Mar 26, 2003	Supplement 24Labeling	Approved	None posted
Dec 16, 1997	Supplement 21Labeling	Approved	None posted
Oct 18, 1996	Supplement 20Labeling	Approved	None posted
Oct 18, 1996	Supplement 19Manufacturing	Approved	None posted
Oct 18, 1996	Supplement 18Manufacturing	Approved	None posted
Oct 18, 1996	Supplement 17Manufacturing	Approved	None posted
Oct 18, 1996	Supplement 16Manufacturing	Approved	None posted
May 9, 1995	Supplement 15Manufacturing	Approved	None posted
May 9, 1995	Supplement 14Manufacturing	Approved	None posted
Sep 24, 1993	Supplement 13Manufacturing	Approved	None posted
Sep 24, 1993	Supplement 12Manufacturing	Approved	None posted
Sep 24, 1993	Supplement 11Manufacturing	Approved	None posted
Sep 24, 1993	Supplement 10Manufacturing	Approved	None posted
Sep 24, 1993	Supplement 9Manufacturing	Approved	None posted
Oct 16, 1991	Supplement 8Labeling	Approved	None posted
Feb 26, 1991	Supplement 7Labeling	Approved	None posted
Feb 26, 1991	Supplement 6Labeling	Approved	None posted
Mar 27, 1989	Supplement 5Manufacturing	Approved	None posted
Aug 26, 1988	Supplement 4Labeling	Approved	None posted
May 5, 1988	Supplement 2Manufacturing	Approved	None posted
Jan 7, 1987	Supplement 1Manufacturing	Approved	None posted
Jan 7, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 70589
Drugs@FDA: Overview at FDA
Company: Upsher-Smith Laboratories

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