Treats constipation. ANDA 90503, held by Fresenius Kabi. Lactulose.
As of Nov 13, 2026, ANDA 90503 (Lactulose), held by Fresenius Kabi, was first approved by FDA on Jan 25, 2012, 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 |
|---|---|---|---|
| Jan 25, 2012 | 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
