General MedicationsSUBCUTANEOUSStandard

LEUPROLIDE ACETATE

Standard Dose

14MG/2.8ML (1MG/0.2ML)

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview LEUPROLIDE ACETATE is listed in Drugs@FDA under application 217957 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient LEUPROLIDE ACETATE Form and strength SOLUTION;SUBCUTANEOUS - 14MG/2.8ML (1MG/0.2ML) Sponsor UBI Submission history Latest submission status date: 2025-09-23 00:00:00.

Structured Monograph

Clinical summary

Approval overview LEUPROLIDE ACETATE is listed in Drugs@FDA under application 217957 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient LEUPROLIDE ACETATE Form and strength SOLUTION;SUBCUTANEOUS - 14MG/2.8ML (1MG/0.2ML) Sponsor UBI Submission history Latest submission status date: 2025-09-23 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.