FDA Summary Basis of Approval for NDA 218771 Almaject Teriparatide Injection

FDA Summary Basis of Approval for NDA 218771 Almaject Teriparatide Injection

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Original Request: A copy of the summary basis of approval, including any associated therapeutic equivalence determination, for NDA 218771 for Almaject, Inc.'s Teriparatide Injection, which was approved by FDA on or about June 4, 2024.
Tags: Pharma, NDA, 2024
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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