Determination That NAMENDA (Memantine Hydrochloride) Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Official abstract: The Food and Drug Administration (FDA, Agency, or we) has determined that NAMENDA (memantine hydrochloride) tablets, 5 milligrams (mg) and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as the ANDAs meet relevant legal and regulatory requirements.