Lactulose

ANDA 74077, held by Pai Holdings Pharm. Lactulose.

As of Nov 13, 2026, ANDA 74077 (Lactulose), held by Pai Holdings Pharm, was first approved by FDA on Jul 3, 1995, with 5 approved supplements and 0 published complete response letters.

First approved: Jul 3, 1995
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jul 3, 1995	Original application	Approved	None posted

Products

1 strengths and forms

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

All 6 submissions, including labeling and manufacturing supplements


Sep 4, 2009	Supplement 7Labeling	Approved	None posted
May 5, 2009	Supplement 5Labeling	Approved	None posted
Oct 9, 1997	Supplement 1Manufacturing	Approved	None posted
Oct 9, 1997	Supplement 2Manufacturing	Approved	None posted
Oct 9, 1997	Supplement 3Manufacturing	Approved	None posted
Jul 3, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 74077
Drugs@FDA: Overview at FDA
Company: PAI Holdings Pharm

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