Leuprolide Acetate

Treats advanced prostatic cancer. ANDA 212963, held by Eugia Pharma. Leuprolide Acetate.

As of Nov 15, 2026, ANDA 212963 (Leuprolide Acetate), held by Eugia Pharma, was first approved by FDA on Jun 6, 2022, with 3 approved supplements and 0 published complete response letters.

First approved: Jun 6, 2022
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Leuprolide acetate injection is indicated in the palliative treatment of advanced prostatic cancer.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jun 6, 2022	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Leuprolide Acetate14MG/2.8ML (1MG/0.2ML) · solution;subcutaneous	Leuprolide Acetate	Rx

All 4 submissions, including labeling and manufacturing supplements


May 6, 2026	Supplement 4Labeling · Standard review	Approved	None posted
Apr 30, 2026	Supplement 3Labeling · Standard review	Approved	None posted
Sep 23, 2025	Supplement 2Labeling · Standard review	Approved	None posted
Jun 6, 2022	Original application	Approved	None posted

Identifiers

Application: ANDA 212963
Drugs@FDA: Overview at FDA
Company: Eugia Pharma

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters