Zdrowie i gospodarka · 19.09.2022
Determination That ENDEP (Amitriptyline Hydrochloride) Oral Concentrate, 40 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that ENDEP (amitriptyline hydrochloride) oral concentrate, 40 milligrams (mg)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for ENDEP (amitriptyline hydrochloride) oral concentrate, 40 mg/mL, if all other legal and regulatory requirements are met.