Heptalac

ANDA 73504, held by Teva Pharms. Lactulose.

As of Nov 13, 2026, ANDA 73504 (Heptalac), held by Teva Pharms, was first approved by FDA on May 28, 1993, with 3 approved supplements and 0 published complete response letters.

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

Products

1 strengths and forms

Product	Active ingredient	Marketing
Heptalac10GM/15ML · solution;oral, rectal	Lactulose	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Mar 23, 1999	Supplement 3Manufacturing	Approved	None posted
May 31, 1996	Supplement 2Manufacturing	Approved	None posted
Jun 30, 1995	Supplement 1Manufacturing	Approved	None posted
May 28, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 73504
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals

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