Zdrowie i gospodarka · 9.01.2008
Determination That INDERAL (Propranolol Hydrochloride) Tablets, 10 Milligrams, 20 Milligrams, and 90 Milligrams Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that INDERAL (propranolol hydrochloride (HCl)) Tablets, 10 milligrams (mg), 20 mg, and 90 mg, were not withdrawn from sale for reasons of safety or effectiveness.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 the drug products, and it will allow FDA to approve ANDAs for propranolol HCl tablets, 10 mg, 20 mg, and 90 mg as long as they meet relevant legal and regulatory requirements.