Amantadine Hydrochloride

ANDA 210403, held by Jubilant Generics. Amantadine Hydrochloride.

As of Nov 15, 2026, ANDA 210403 (Amantadine Hydrochloride), held by Jubilant Generics, was first approved by FDA on Feb 7, 2018, with 2 approved supplements and 0 published complete response letters.

First approved: Feb 7, 2018
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Feb 7, 2018	Original application	Approved	None posted

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements


Jul 10, 2025	Supplement 11Labeling · Standard review	Approved	None posted
Oct 25, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Feb 7, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 210403
Drugs@FDA: Overview at FDA
Company: Jubilant Generics

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