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General MedicationsSUBCUTANEOUSStandard

GONAL-F RFF

FOLLITROPIN ALFA/BETA

Standard Dose
75 IU/VIAL
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview GONAL-F RFF is listed in Drugs@FDA under application 021765 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient FOLLITROPIN ALFA/BETA Form and strength INJECTABLE;SUBCUTANEOUS - 75 IU/VIAL Sponsor EMD SERONO Submission history Latest submission status date: 2023-11-13 00:00:00.

Structured Monograph

Clinical summary

Approval overview GONAL-F RFF is listed in Drugs@FDA under application 021765 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient FOLLITROPIN ALFA/BETA Form and strength INJECTABLE;SUBCUTANEOUS - 75 IU/VIAL Sponsor EMD SERONO Submission history Latest submission status date: 2023-11-13 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.