ANDA 75640, held by Quagen. Hydrochlorothiazide.
As of Nov 15, 2026, ANDA 75640 (Hydrochlorothiazide), held by Quagen, was first approved by FDA on Jan 28, 2000, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 28, 2000 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydrochlorothiazide12.5MG · capsule;oral | Hydrochlorothiazide | Discontinued |
| Jun 6, 2022 | Supplement 23Labeling · Standard review | Approved | None posted |
| Aug 29, 2012 | Supplement 15Labeling · Standard review | Approved | None posted |
| May 10, 2002 | Supplement 1Manufacturing | Approved | None posted |
| Jan 28, 2000 | 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
