Memantine Hydrochloride

ANDA 90073, held by Pharmazone. Memantine Hydrochloride.

As of Nov 15, 2026, ANDA 90073 (Memantine Hydrochloride), held by Pharmazone, was first approved by FDA on Sep 4, 2015, with 1 approved supplement and 0 published complete response letters.

First approved: Sep 4, 2015
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 4, 2015	Original application	Approved	Letter

Products

2 strengths and forms


Memantine Hydrochloride5MG · tablet;oral	Memantine Hydrochloride	Discontinued
Memantine Hydrochloride10MG · tablet;oral	Memantine Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jan 25, 2021	Supplement 1Labeling · Standard review	Approved	None posted
Sep 4, 2015	Original application	Approved	Letter

Identifiers

Application: ANDA 90073
Drugs@FDA: Overview at FDA
Company: Pharmazone

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