HHS · Notice · Rel 100 (Federal Register (major agencies))
Determination That RASUVO (Methotrexate) Solution, 27.5 Milligrams/0.55 Milliliter (27.5 Milligrams/0.55 Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Other · Health / life sciences · general, public-health, fda-guidance
Source summary
The Food and Drug Administration (FDA, Agency, or we) has determined that RASUVO (methotrexate) solution, 27.5 milligrams (mg)/ 0.55 milliliter (mL) (27.5 mg/0.55 mL), was not withdrawn from sale for reasons of safety or effectiveness.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 RASUVO (methotrexate) solution, 27.5 mg/0.55 mL (27.5 mg/0.55 mL), if all other legal and regulatory requirements are met.
Analyst note
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