The Food and Drug Administration (FDA or Agency) has determined that ELAVIL (amitriptyline hydrochloride) oral tablets, 10 milligrams (mg), 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for amitriptyline hydrochloride oral tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg, if all other legal and regulatory requirements are met.
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Determination That ELAVIL (Amitriptyline Hydrochloride) Oral Tablets, 10, 25, 50, 75, 100, and 150 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that ELAVIL (amitriptyline hydrochloride) oral tablets, 10 milligrams (mg), 25 mg, 50 mg, 75 mg, 100 mg, and 150 ...
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82 FR 49032
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“Determination That ELAVIL (Amitriptyline Hydrochloride) Oral Tablets, 10, 25, 50, 75, 100, and 150 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness,” thefederalregister.org (October 23, 2017), https://thefederalregister.org/documents/2017-22892/determination-that-elavil-amitriptyline-hydrochloride-oral-tablets-10-25-50-75-100-and-150-milligrams-were-not-withdrawn.