Pentamidine Isethionate

ANDA 73617, held by Baxter Hlthcare. Pentamidine Isethionate.

As of Nov 15, 2026, ANDA 73617 (Pentamidine Isethionate), held by Baxter Hlthcare, was first approved by FDA on Dec 18, 1995, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 18, 1995
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Dec 18, 1995	Original application	Approved	None posted

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements


Jul 11, 1997	Supplement 2Labeling	Approved	None posted
Sep 18, 1996	Supplement 1Labeling	Approved	None posted
Dec 18, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 73617
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

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