Pentamidine Isethionate

ANDA 73479, held by Hospira. Pentamidine Isethionate.

As of Nov 15, 2026, ANDA 73479 (Pentamidine Isethionate), held by Hospira, was first approved by FDA on Jun 30, 1992, with 8 approved supplements and 0 published complete response letters.

First approved: Jun 30, 1992
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Jun 30, 1992	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Pentamidine Isethionate300MG/VIAL · injectable;injection	Pentamidine Isethionate	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Apr 10, 2002	Supplement 9Manufacturing	Approved	None posted
Mar 12, 2002	Supplement 10Manufacturing	Approved	None posted
May 27, 1999	Supplement 8Labeling	Approved	None posted
Dec 9, 1998	Supplement 7Manufacturing	Approved	None posted
Nov 20, 1996	Supplement 4Labeling	Approved	None posted
Jun 12, 1995	Supplement 3Manufacturing	Approved	None posted
Jul 15, 1993	Supplement 2Labeling	Approved	None posted
Jun 1, 1993	Supplement 1Manufacturing	Approved	None posted
Jun 30, 1992	Original application	Approved	Review

Identifiers

Application: ANDA 73479
Drugs@FDA: Overview at FDA
Company: Hospira

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