Enulose

ANDA 71548, held by Actavis Mid Atlantic. Lactulose.

As of Nov 13, 2026, ANDA 71548 (Enulose), held by Actavis Mid Atlantic, was first approved by FDA on Aug 15, 1988, with 13 approved supplements and 0 published complete response letters.

First approved: Aug 15, 1988
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Aug 15, 1988	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Enulose10GM/15ML · solution;oral, rectal	Lactulose	Discontinued

All 14 submissions, including labeling and manufacturing supplements


Dec 20, 2009	Supplement 38Labeling	Approved	None posted
Aug 7, 1998	Supplement 24Manufacturing	Approved	None posted
Aug 19, 1996	Supplement 22Manufacturing	Approved	None posted
Sep 9, 1994	Supplement 21Manufacturing	Approved	None posted
Aug 3, 1993	Supplement 20Manufacturing	Approved	None posted
Jun 11, 1993	Supplement 18Manufacturing	Approved	None posted
Jun 11, 1993	Supplement 19Manufacturing	Approved	None posted
Feb 8, 1993	Supplement 16Manufacturing	Approved	None posted
Apr 6, 1992	Supplement 14Manufacturing	Approved	None posted
Oct 16, 1991	Supplement 12Manufacturing	Approved	None posted
Sep 28, 1990	Supplement 15Manufacturing	Approved	None posted
Jul 31, 1990	Supplement 13Labeling	Approved	None posted
Dec 15, 1988	Supplement 2Manufacturing	Approved	None posted
Aug 15, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 71548
Drugs@FDA: Overview at FDA
Company: Actavis Mid Atlantic LLC

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