Memantine Hydrochloride

ANDA 200155, held by Torrent. Memantine Hydrochloride.

As of Nov 15, 2026, ANDA 200155 (Memantine Hydrochloride), held by Torrent, was first approved by FDA on Oct 13, 2015, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 13, 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
Oct 13, 2015	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 9, 2021	Supplement 1Labeling · Standard review	Approved	None posted
Oct 13, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 200155
Drugs@FDA: Overview at FDA
Company: Torrent 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