Lactulose

Treats constipation. ANDA 74623, held by Pharm Assoc. Lactulose.

As of Nov 13, 2026, ANDA 74623 (Lactulose), held by Pharm Assoc, was first approved by FDA on Jul 30, 1996, with 3 approved supplements and 0 published complete response letters.

First approved: Jul 30, 1996
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Jul 30, 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


Mar 24, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Mar 24, 2020	Supplement 11Labeling · Standard review	Approved	None posted
Mar 24, 2020	Supplement 12Labeling · Standard review	Approved	None posted
Jul 30, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 74623
Drugs@FDA: Overview at FDA
Company: Pharmaceutical Associates

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