Amantadine Hydrochloride

ANDA 72655, held by G And W Labs Inc. Amantadine Hydrochloride.

As of Nov 15, 2026, ANDA 72655 (Amantadine Hydrochloride), held by G And W Labs Inc, was first approved by FDA on Oct 30, 1990, with 10 approved supplements and 0 published complete response letters.

First approved: Oct 30, 1990
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Oct 30, 1990	Original application	Approved	None posted

Products

1 strengths and forms

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

All 11 submissions, including labeling and manufacturing supplements


Jul 29, 2011	Supplement 18Labeling	Approved	None posted
Dec 16, 1998	Supplement 11Manufacturing	Approved	None posted
Sep 8, 1997	Supplement 9Manufacturing	Approved	None posted
Jan 13, 1994	Supplement 8Labeling	Approved	None posted
Aug 10, 1993	Supplement 5Manufacturing	Approved	None posted
Aug 10, 1993	Supplement 6Manufacturing	Approved	None posted
Aug 10, 1993	Supplement 7Manufacturing	Approved	None posted
Nov 2, 1992	Supplement 4Manufacturing	Approved	None posted
Dec 30, 1991	Supplement 3Labeling	Approved	None posted
Sep 4, 1991	Supplement 1Labeling	Approved	None posted
Oct 30, 1990	Original application	Approved	None posted

Identifiers

Application: ANDA 72655
Drugs@FDA: Overview at FDA
Company: G & W 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