Memantine Hydrochloride

ANDA 206855, held by Puracap Pharm LLC. Memantine Hydrochloride.

As of Nov 15, 2026, ANDA 206855 (Memantine Hydrochloride), held by Puracap Pharm LLC, was first approved by FDA on Nov 17, 2015, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 17, 2015
Review: Standard
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
Nov 17, 2015	Original application	Approved	None posted

Products

2 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Jun 28, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Nov 17, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 206855
Drugs@FDA: Overview at FDA
Company: PuraCap Pharmaceutical

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