Leuprolide Acetate

ANDA 215336, held by Amneal. Leuprolide Acetate.

As of Nov 15, 2026, ANDA 215336 (Leuprolide Acetate), held by Amneal, was first approved by FDA on Oct 28, 2022, with 3 approved supplements and 0 published complete response letters.

First approved: Oct 28, 2022
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Oct 28, 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 14Labeling · Standard review	Approved	None posted
Apr 30, 2026	Supplement 12Labeling · Standard review	Approved	None posted
Sep 23, 2025	Supplement 9Labeling · Standard review	Approved	None posted
Oct 28, 2022	Original application	Approved	None posted

Identifiers

Application: ANDA 215336
Drugs@FDA: Overview at FDA
Company: Amneal Pharmaceuticals

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