Isoflurane

ANDA 74393, held by Watson Labs Inc. Isoflurane.

As of Nov 15, 2026, ANDA 74393 (Isoflurane), held by Watson Labs Inc, was first approved by FDA on May 12, 1995, with 12 approved supplements and 0 published complete response letters.

First approved: May 12, 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
May 12, 1995	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Isoflurane99.9% · liquid;inhalation	Isoflurane	Discontinued

All 13 submissions, including labeling and manufacturing supplements


Dec 8, 2000	Supplement 12Manufacturing	Approved	None posted
Nov 10, 1999	Supplement 11Labeling	Approved	None posted
Jul 27, 1999	Supplement 10Labeling	Approved	None posted
Apr 23, 1999	Supplement 6Manufacturing	Approved	None posted
Apr 23, 1999	Supplement 7Manufacturing	Approved	None posted
Apr 23, 1999	Supplement 8Labeling	Approved	None posted
Apr 23, 1999	Supplement 9Manufacturing	Approved	None posted
Apr 3, 1997	Supplement 4Manufacturing	Approved	None posted
Apr 3, 1997	Supplement 5Manufacturing	Approved	None posted
Sep 19, 1996	Supplement 3Manufacturing	Approved	None posted
Mar 25, 1996	Supplement 1Manufacturing	Approved	None posted
Mar 25, 1996	Supplement 2Labeling	Approved	None posted
May 12, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 74393
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