ANDA 75907, held by Prinston. Hydrochlorothiazide.
As of Nov 15, 2026, ANDA 75907 (Hydrochlorothiazide), held by Prinston, was first approved by FDA on Sep 17, 2002, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 17, 2002 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydrochlorothiazide12.5MG · capsule;oral | Hydrochlorothiazide | Rx |
| Jun 6, 2022 | Supplement 15Labeling · Standard review | Approved | None posted |
| Jul 7, 2011 | Supplement 6Labeling | Approved | None posted |
| Sep 17, 2002 | 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
