ANDA 78430, held by Ani Pharms. Lactulose.
As of Nov 13, 2026, ANDA 78430 (Lactulose), held by Ani Pharms, was first approved by FDA on Nov 28, 2007, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 28, 2007 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lactulose10GM/15ML ยท solution;oral | Lactulose | Discontinued |
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
