Department of Health and Human Services December 3, 2009 – Federal Register Recent Federal Regulation Documents
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Determination That MESANTOIN (Mephenytoin) Tablets, 100 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) is announcing its determination that MESANTOIN (mephenytoin) Tablets, 100 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for mephenytoin tablets, 100 mg, if all other legal and regulatory requirements are met.
Determination That ABILIFY DISCMELT (Aripiprazole) Orally Disintegrating Tablets, 20 Milligrams and 30 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that ABILIFY DISCMELT (aripiprazole) orally disintegrating tablets, 20 milligrams (mg) and 30 mg, were not withdrawn from sale for reasons of safety or effectiveness.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 aripiprazole orally disintegrating tablets, 20 mg and 30 mg, if all other legal and regulatory requirements are met.
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