Lactulose

ANDA 74602, held by Aurobindo Pharma Ltd. Lactulose.

As of Nov 13, 2026, ANDA 74602 (Lactulose), held by Aurobindo Pharma Ltd, was first approved by FDA on Nov 14, 1996, with 3 approved supplements and 0 published complete response letters.

First approved: Nov 14, 1996
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Nov 14, 1996	Original application	Approved	None posted

Products

1 strengths and forms

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

All 4 submissions, including labeling and manufacturing supplements


Jan 4, 2001	Supplement 3Labeling	Approved	None posted
Jul 15, 1999	Supplement 2Labeling	Approved	None posted
Mar 12, 1999	Supplement 1Manufacturing	Approved	None posted
Nov 14, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 74602
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

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