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General MedicationsORALGeneric

OSPEMIFENE

OSPEMIFENE

Standard Dose
60MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview OSPEMIFENE is listed in Drugs@FDA under application 215574 (ANDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient OSPEMIFENE Form and strength TABLET;ORAL - 60MG Sponsor HETERO LABS LTD V Submission history Latest submission status date: 2025-07-25 00:00:00.

Structured Monograph

Clinical summary

Approval overview OSPEMIFENE is listed in Drugs@FDA under application 215574 (ANDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient OSPEMIFENE Form and strength TABLET;ORAL - 60MG Sponsor HETERO LABS LTD V Submission history Latest submission status date: 2025-07-25 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.