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General MedicationsINJECTIONStandard

GANIRELIX ACETATE

GANIRELIX ACETATE

Standard Dose
250MCG/0.5ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview GANIRELIX ACETATE is listed in Drugs@FDA under application 219454 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient GANIRELIX ACETATE Form and strength INJECTABLE;INJECTION - 250MCG/0.5ML Sponsor TRIS PHARMA INC Submission history Latest submission status date: 2025-06-27 00:00:00.

Structured Monograph

Clinical summary

Approval overview GANIRELIX ACETATE is listed in Drugs@FDA under application 219454 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient GANIRELIX ACETATE Form and strength INJECTABLE;INJECTION - 250MCG/0.5ML Sponsor TRIS PHARMA INC Submission history Latest submission status date: 2025-06-27 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.