Memantine Hydrochloride

ANDA 90044, held by Orbion Pharms. Memantine Hydrochloride.

As of Nov 15, 2026, ANDA 90044 (Memantine Hydrochloride), held by Orbion Pharms, was first approved by FDA on Mar 12, 2012, with 2 approved supplements and 0 published complete response letters.

First approved: Mar 12, 2012
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
Mar 12, 2012	Original application	Approved	Letter Letter

Products

2 strengths and forms


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

All 3 submissions, including labeling and manufacturing supplements


Jan 21, 2021	Supplement 2Labeling · Standard review	Approved	None posted
Jan 6, 2016	Supplement 1Labeling · Standard review	Approved	None posted
Mar 12, 2012	Original application	Approved	Letter Letter

Identifiers

Application: ANDA 90044
Drugs@FDA: Overview at FDA
Company: Orbion 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