Summary Basis of Approval – CycloSPORINE Ophthalmic Emulsion (ANDA 209811, Deva Holding AS)

Summary Basis of Approval – CycloSPORINE Ophthalmic Emulsion (ANDA 209811, Deva Holding AS)

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Request Contents: CycloSPORINE Ophthalmic Emulsion, 0.05% – Summary Basis of Approval (including Bioequivalence study & Manufacturing Controls) for ANDA 209811 - Deva Holding AS
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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