General MedicationsSUBCUTANEOUSGeneric

LUPRON

LEUPROLIDE ACETATE

Standard Dose

14MG/2.8ML (1MG/0.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 is listed in Drugs@FDA under application 019010 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient LEUPROLIDE ACETATE Form and strength SOLUTION;SUBCUTANEOUS - 14MG/2.8ML (1MG/0.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ABBVIE ENDOCRINE INC Submission history Latest submission status date: 2025-09-30 00:00:00.

Structured Monograph

Clinical summary

Approval overview LUPRON is listed in Drugs@FDA under application 019010 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient LEUPROLIDE ACETATE Form and strength SOLUTION;SUBCUTANEOUS - 14MG/2.8ML (1MG/0.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ABBVIE ENDOCRINE INC Submission history Latest submission status date: 2025-09-30 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.