Treats constipation. ANDA 75911, held by Pharmobedient. Lactulose.
As of Nov 13, 2026, ANDA 75911 (Lactulose), held by Pharmobedient, was first approved by FDA on Feb 21, 2002, with 1 approved supplement 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 |
|---|---|---|---|
| Feb 21, 2002 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lactulose10GM/15ML · solution;oral | Lactulose | Rx |
| Sep 17, 2024 | Supplement 12Manufacturing | Approved | None posted |
| Feb 21, 2002 | Original application | Approved |
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
