Treats constipation. ANDA 75993, held by Lannett Co Inc. Lactulose.
As of Nov 13, 2026, ANDA 75993 (Lactulose), held by Lannett Co Inc, was first approved by FDA on Jul 26, 2001, with 0 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 26, 2001 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lactulose10GM/15ML · solution;oral | Lactulose | Rx |
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
