Treats constipation. ANDA 207786, held by Pharmazone. Lactulose.
As of Nov 13, 2026, ANDA 207786 (Lactulose), held by Pharmazone, was first approved by FDA on Jun 11, 2018, 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 |
|---|---|---|---|
| Jun 11, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lactulose10GM/15ML · solution;oral | Lactulose | Rx |
| Sep 8, 2021 | Supplement 2Manufacturing | Approved | None posted |
| Jun 11, 2018 | Original application | Approved | None posted |
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
