Memantine Hydrochloride

ANDA 90052, held by Teva Pharms. Memantine Hydrochloride.

As of Nov 15, 2026, ANDA 90052 (Memantine Hydrochloride), held by Teva Pharms, was first approved by FDA on Oct 25, 2011, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 25, 2011
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
Oct 25, 2011	Original application	Approved	None posted

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


Nov 18, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Oct 25, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 90052
Drugs@FDA: Overview at FDA
Company: Teva 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