For type 2 diabetes mellitus. ANDA 203965, held by Orient Pharma. Miglitol.
As of Nov 14, 2026, ANDA 203965 (Miglitol), held by Orient Pharma, was first approved by FDA on Feb 24, 2015, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Miglitol tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 24, 2015 | Original application | Approved |
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
