General MedicationsINTRAMUSCULARStandard

LEUPROLIDE ACETATE FOR DEPOT SUSPENSION

LEUPROLIDE ACETATE

Standard Dose

22.5MG/VIAL

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview LEUPROLIDE ACETATE FOR DEPOT SUSPENSION is listed in Drugs@FDA under application 205054 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient LEUPROLIDE ACETATE Form and strength FOR SUSPENSION;INTRAMUSCULAR - 22.5MG/VIAL Sponsor INVAGEN PHARMS Submission history Latest submission status date: 2024-11-14 00:00:00.

Structured Monograph

Clinical summary

Approval overview LEUPROLIDE ACETATE FOR DEPOT SUSPENSION is listed in Drugs@FDA under application 205054 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient LEUPROLIDE ACETATE Form and strength FOR SUSPENSION;INTRAMUSCULAR - 22.5MG/VIAL Sponsor INVAGEN PHARMS Submission history Latest submission status date: 2024-11-14 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.