Amantadine Hydrochloride

ANDA 77992, held by Ph Health. Amantadine Hydrochloride.

As of Nov 15, 2026, ANDA 77992 (Amantadine Hydrochloride), held by Ph Health, was first approved by FDA on Dec 12, 2006, with 4 approved supplements and 0 published complete response letters.

First approved: Dec 12, 2006
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Dec 12, 2006	Original application	Approved	None posted

Products

1 strengths and forms

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

All 5 submissions, including labeling and manufacturing supplements


Jul 10, 2025	Supplement 11Labeling · Standard review	Approved	None posted
Jul 29, 2011	Supplement 6Labeling	Approved	None posted
Mar 25, 2009	Supplement 5Labeling	Approved	None posted
May 31, 2007	Supplement 1Labeling	Approved	None posted
Dec 12, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 77992
Drugs@FDA: Overview at FDA
Company: PH Health

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