ANDA 84776, held by Inwood Labs. Hydrochlorothiazide.
As of Nov 15, 2026, ANDA 84776 (Hydrochlorothiazide), held by Inwood Labs, was first approved by FDA on Sep 21, 1976, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 21, 1976 | Original application | Approved | None posted |
| Hydrochlorothiazide25MG · tablet;oral | Hydrochlorothiazide | Discontinued |
| Hydrochlorothiazide50MG · 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
