ANDA 75055, held by Ivax Sub Teva Pharms. Captopril; Hydrochlorothiazide.
As of Nov 15, 2026, ANDA 75055 (Captopril And Hydrochlorothiazide), held by Ivax Sub Teva Pharms, was first approved by FDA on Jun 18, 1998, with 9 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 18, 1998 | Original application | Approved |
| Captopril And Hydrochlorothiazide25MG;15MG · tablet;oral | Captopril; Hydrochlorothiazide | Discontinued |
| Captopril And Hydrochlorothiazide25MG;25MG · tablet;oral | Captopril; Hydrochlorothiazide | Discontinued |
| Captopril And Hydrochlorothiazide50MG;25MG · tablet;oral | Captopril; Hydrochlorothiazide | Discontinued |
| Captopril And Hydrochlorothiazide50MG;15MG · tablet;oral | Captopril; Hydrochlorothiazide | Discontinued |
| Jul 29, 2002 | Supplement 10Manufacturing | Approved | None posted |
| Mar 12, 2002 | Supplement 9Manufacturing | Approved | None posted |
| Nov 7, 2001 | Supplement 7Manufacturing | Approved | None posted |
| Apr 13, 2001 | Supplement 4Manufacturing | Approved | None posted |
| Apr 13, 2001 | Supplement 5Manufacturing | Approved | None posted |
| Apr 13, 2001 | Supplement 6Manufacturing | Approved | None posted |
| Mar 28, 2000 | Supplement 3Manufacturing | Approved | None posted |
| Jan 28, 2000 | Supplement 2Manufacturing | Approved | None posted |
| Jul 23, 1999 | Supplement 1Manufacturing | Approved | None posted |
| Jun 18, 1998 | 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
