Treats constipation. ANDA 217914, held by Pai Holdings. Lactulose.
As of Nov 13, 2026, ANDA 217914 (Lactulose), held by Pai Holdings, was first approved by FDA on Mar 14, 2025, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Lactulose for Oral Solution is indicated for the treatment of constipation. In patients with a history of chronic constipation, lactulose therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 14, 2025 | 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
