ANDA 83607, held by Impax Labs. Hydrochlorothiazide.
As of Nov 15, 2026, ANDA 83607 (Hydrochlorothiazide), held by Impax Labs, was first approved by FDA on Aug 19, 1977, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 19, 1977 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydrochlorothiazide50MG ยท tablet;oral | Hydrochlorothiazide | 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
