Amantadine Hydrochloride

ANDA 73115, held by Teva Pharms. Amantadine Hydrochloride.

As of Nov 15, 2026, ANDA 73115 (Amantadine Hydrochloride), held by Teva Pharms, was first approved by FDA on Aug 23, 1991, with 7 approved supplements and 0 published complete response letters.

First approved: Aug 23, 1991
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Aug 23, 1991	Original application	Approved	None posted

Products

1 strengths and forms

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

All 8 submissions, including labeling and manufacturing supplements


Oct 7, 1999	Supplement 7Manufacturing	Approved	None posted
Mar 23, 1999	Supplement 6Manufacturing	Approved	None posted
Nov 16, 1998	Supplement 5Manufacturing	Approved	None posted
Jun 11, 1998	Supplement 4Manufacturing	Approved	None posted
Sep 30, 1997	Supplement 3Manufacturing	Approved	None posted
May 31, 1996	Supplement 2Manufacturing	Approved	None posted
Dec 3, 1993	Supplement 1Labeling	Approved	None posted
Aug 23, 1991	Original application	Approved	None posted

Identifiers

Application: ANDA 73115
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals

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