Amantadine Hydrochloride

ANDA 207570, held by Invagen Pharms. Amantadine Hydrochloride.

As of Nov 15, 2026, ANDA 207570 (Amantadine Hydrochloride), held by Invagen Pharms, was first approved by FDA on Sep 30, 2016, with 1 approved supplement and 0 published complete response letters.

First approved: Sep 30, 2016
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Sep 30, 2016	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Jul 10, 2025	Supplement 2Labeling · Standard review	Approved	None posted
Sep 30, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 207570
Drugs@FDA: Overview at FDA
Company: InvaGen Pharmaceuticals, Inc.

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