Alprostadil

As of Nov 14, 2026, ANDA 74815 (Alprostadil), held by Hikma, was first approved by FDA on Jan 20, 1998, with 5 approved supplements and 0 published complete response letters.

First approved: Jan 20, 1998
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jan 20, 1998	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Alprostadil0.5MG/ML · injectable;injection	Alprostadil	Rx

All 6 submissions, including labeling and manufacturing supplements


Sep 11, 2002	Supplement 5Manufacturing	Approved	None posted
Apr 3, 2001	Supplement 4Manufacturing	Approved	None posted
Jul 11, 2000	Supplement 1Manufacturing	Approved	None posted
Jul 11, 2000	Supplement 2Manufacturing	Approved	None posted
Jul 11, 2000	Supplement 3Labeling	Approved	None posted
Jan 20, 1998	Original application	Approved	Review

Identifiers

Application: ANDA 74815
Drugs@FDA: Overview at FDA
Company: Hikma

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