General MedicationsINTRAMUSCULARGeneric

LUPRON DEPOT-PED KIT

LEUPROLIDE ACETATE

Standard Dose

3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Discontinued

Summary

Approval overview LUPRON DEPOT-PED KIT is listed in Drugs@FDA under application 020263 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient LEUPROLIDE ACETATE Form and strength POWDER;INTRAMUSCULAR - 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ABBVIE ENDOCRINE INC Submission history Latest submission status date: 2025-11-14 00:00:00.

Structured Monograph

Clinical summary

Approval overview LUPRON DEPOT-PED KIT is listed in Drugs@FDA under application 020263 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient LEUPROLIDE ACETATE Form and strength POWDER;INTRAMUSCULAR - 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ABBVIE ENDOCRINE INC Submission history Latest submission status date: 2025-11-14 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.