Pentamidine Isethionate

ANDA 74303, held by Watson Labs. Pentamidine Isethionate.

As of Nov 15, 2026, ANDA 74303 (Pentamidine Isethionate), held by Watson Labs, was first approved by FDA on Aug 17, 1995, with 12 approved supplements and 0 published complete response letters.

First approved: Aug 17, 1995
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Aug 17, 1995	Original application	Approved	None posted

Products

1 strengths and forms

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

All 13 submissions, including labeling and manufacturing supplements


Feb 19, 1999	Supplement 12Manufacturing	Approved	None posted
Feb 2, 1999	Supplement 11Manufacturing	Approved	None posted
Aug 7, 1998	Supplement 8Labeling	Approved	None posted
Apr 3, 1998	Supplement 10Manufacturing	Approved	None posted
Apr 25, 1997	Supplement 7Manufacturing	Approved	None posted
Feb 28, 1997	Supplement 5Manufacturing	Approved	None posted
Jan 22, 1997	Supplement 9Manufacturing	Approved	None posted
Dec 4, 1996	Supplement 6Manufacturing	Approved	None posted
Nov 27, 1996	Supplement 3Manufacturing	Approved	None posted
Nov 4, 1996	Supplement 2Manufacturing	Approved	None posted
Aug 14, 1996	Supplement 4Labeling	Approved	None posted
Apr 1, 1996	Supplement 1Manufacturing	Approved	None posted
Aug 17, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 74303
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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