Treats constipation. ANDA 209517, held by Chartwell Rx. Lactulose.
As of Nov 13, 2026, ANDA 209517 (Lactulose), held by Chartwell Rx, was first approved by FDA on Nov 23, 2018, with 0 approved supplements and 0 published complete response letters.
INDICATION 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 |
|---|---|---|---|
| Nov 23, 2018 | 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
