Acilac

ANDA 73685, held by Nostrum Labs. Lactulose.

As of Nov 13, 2026, ANDA 73685 (Acilac), held by Nostrum Labs, was first approved by FDA on May 28, 1993, with 12 approved supplements and 0 published complete response letters.

First approved: May 28, 1993
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 28, 1993	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Acilac10GM/15ML · solution;oral, rectal	Lactulose	Discontinued

All 13 submissions, including labeling and manufacturing supplements


Jul 15, 2003	Supplement 13Labeling	Approved	None posted
Jun 26, 2001	Supplement 12Manufacturing	Approved	None posted
Oct 25, 2000	Supplement 11Manufacturing	Approved	None posted
Jun 20, 2000	Supplement 10Manufacturing	Approved	None posted
Mar 13, 1998	Supplement 8Labeling	Approved	None posted
Mar 13, 1998	Supplement 7Labeling	Approved	None posted
Feb 24, 1998	Supplement 5Manufacturing	Approved	None posted
Jan 23, 1998	Supplement 9Manufacturing	Approved	None posted
Jan 23, 1998	Supplement 4Labeling	Approved	None posted
Jan 23, 1998	Supplement 3Manufacturing	Approved	None posted
Dec 1, 1997	Supplement 6Manufacturing	Approved	None posted
Jan 27, 1995	Supplement 1Manufacturing	Approved	None posted
May 28, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 73685
Drugs@FDA: Overview at FDA
Company: Nostrum Laboratories, Inc.

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