Manages hypertension. ANDA 83177, held by Ivax Sub Teva Pharms. Hydrochlorothiazide.
As of Nov 15, 2026, ANDA 83177 (Hydrochlorothiazide), held by Ivax Sub Teva Pharms, was first approved by FDA on Jan 12, 1973, with 36 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 12, 1973 | Original application | Approved | None posted |
| Hydrochlorothiazide25MG · tablet;oral | Hydrochlorothiazide | RxReference drug |
| Hydrochlorothiazide50MG · tablet;oral | Hydrochlorothiazide | RxReference drug |
| Hydrochlorothiazide12.5MG · tablet;oral | Hydrochlorothiazide | RxReference drug |
| Sep 19, 2024 | Supplement 236Manufacturing | Approved | None posted |
| Aug 20, 2020 | Supplement 229Labeling · Standard review | Approved | None posted |
| Jan 19, 2012 | Supplement 221Labeling | Approved | None posted |
| Jan 7, 2005 | Supplement 205Labeling | Approved | None posted |
| Jul 7, 2004 | Supplement 200Labeling | Approved | None posted |
| Nov 15, 2002 | Supplement 196Manufacturing | Approved | None posted |
| Aug 22, 2002 | Supplement 193Manufacturing | Approved | None posted |
| Jul 29, 2002 | Supplement 197Manufacturing | Approved | None posted |
| Sep 12, 2001 | Supplement 195Manufacturing | Approved | None posted |
| Feb 3, 2000 | Supplement 192Labeling | Approved | None posted |
| Feb 3, 2000 | Supplement 190Manufacturing | Approved | None posted |
| Jan 28, 2000 | Supplement 191Manufacturing | Approved | None posted |
| Apr 30, 1999 | Supplement 188Manufacturing | Approved | None posted |
| Apr 30, 1999 | Supplement 187Manufacturing | Approved | None posted |
| Apr 30, 1999 | Supplement 186Manufacturing | Approved | None posted |
| Dec 9, 1998 | Supplement 185Manufacturing | Approved | None posted |
| May 13, 1998 | Supplement 184Manufacturing | Approved | None posted |
| Jan 13, 1998 | Supplement 183Manufacturing | Approved | None posted |
| May 30, 1997 | Supplement 182Manufacturing | Approved | None posted |
| Apr 24, 1996 | Supplement 181Manufacturing | Approved | None posted |
| Oct 6, 1995 | Supplement 177Manufacturing | Approved | None posted |
| Aug 17, 1995 | Supplement 180Labeling | Approved | None posted |
| Jun 3, 1993 | Supplement 179Labeling | Approved | None posted |
| Mar 12, 1993 | Supplement 178Labeling | Approved | None posted |
| Sep 9, 1992 | Supplement 176Manufacturing | Approved | None posted |
| Sep 9, 1992 | Supplement 175Manufacturing | Approved | None posted |
| Nov 10, 1988 | Supplement 174Bioequivalence | Approved | None posted |
| Mar 31, 1988 | Supplement 170Manufacturing | Approved | None posted |
| Mar 31, 1988 | Supplement 169Manufacturing | Approved | None posted |
| Jun 29, 1987 | Supplement 168Manufacturing | Approved | None posted |
| Feb 20, 1987 | Supplement 164Manufacturing | Approved | None posted |
| Jan 14, 1987 | Supplement 166Manufacturing | Approved | None posted |
| Jan 14, 1987 | Supplement 165Manufacturing | Approved | None posted |
| Mar 30, 1982 | Supplement 158Manufacturing | Approved | None posted |
| Mar 30, 1982 | Supplement 157Manufacturing | Approved | None posted |
| Mar 30, 1982 | Supplement 156Manufacturing | Approved | None posted |
| Jan 12, 1973 | Original application | Approved | None posted |
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
