ANDA 89835, held by Chartwell Rx. Methyclothiazide.
As of Nov 15, 2026, ANDA 89835 (Methyclothiazide), held by Chartwell Rx, was first approved by FDA on Aug 18, 1988, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 18, 1988 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Methyclothiazide2.5MG ยท tablet;oral | Methyclothiazide | Discontinued |
| May 9, 2001 | Supplement 3Manufacturing | Approved | None posted |
| Mar 8, 1995 | Supplement 2Manufacturing | Approved | None posted |
| Feb 14, 1992 | Supplement 1Labeling | Approved | None posted |
| Aug 18, 1988 | 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
