Lactulose

ANDA 74138, held by Vistapharm LLC. Lactulose.

As of Nov 13, 2026, ANDA 74138 (Lactulose), held by Vistapharm LLC, was first approved by FDA on Sep 30, 1992, with 12 approved supplements and 0 published complete response letters.

First approved: Sep 30, 1992
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
Sep 30, 1992	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lactulose10GM/15ML · solution;oral	Lactulose	Discontinued

All 13 submissions, including labeling and manufacturing supplements


Nov 28, 2001	Supplement 13Manufacturing	Approved	None posted
Mar 27, 2000	Supplement 12Manufacturing	Approved	None posted
Feb 24, 1998	Supplement 9Labeling	Approved	None posted
Dec 22, 1997	Supplement 11Manufacturing	Approved	None posted
Dec 22, 1997	Supplement 10Manufacturing	Approved	None posted
Jan 31, 1997	Supplement 8Labeling	Approved	None posted
Jan 31, 1997	Supplement 7Manufacturing	Approved	None posted
Sep 20, 1996	Supplement 6Labeling	Approved	None posted
Aug 7, 1996	Supplement 5Labeling	Approved	None posted
Aug 7, 1996	Supplement 4Manufacturing	Approved	None posted
Aug 7, 1996	Supplement 3Manufacturing	Approved	None posted
Feb 22, 1994	Supplement 1Manufacturing	Approved	None posted
Sep 30, 1992	Original application	Approved	None posted

Identifiers

Application: ANDA 74138
Drugs@FDA: Overview at FDA
Company: VistaPharm

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