NDA 17386, held by I3 Pharms. Metolazone.
As of Nov 13, 2026, NDA 17386 (Zaroxolyn), held by I3 Pharms, was first approved by FDA on Nov 27, 1973, with 33 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 27, 1973 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zaroxolyn2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Metolazone | DiscontinuedReference drug |
| Zaroxolyn5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Metolazone | DiscontinuedReference drug |
| Zaroxolyn10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Metolazone | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 24, 2019 | Supplement 43Manufacturing · Standard review | Approved | |
| Mar 30, 2015 | Supplement 40Manufacturing · Standard review | Approved | |
| Nov 22, 2013 | Supplement 39Manufacturing · Standard review | Approved | |
| Aug 19, 2003 | Supplement 36Labeling · Standard review | Approved | |
| Oct 29, 2002 | Supplement 34Labeling · Standard review | Approved | |
| Apr 15, 2002 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Oct 18, 2001 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Aug 10, 2001 | Supplement 32Labeling · Standard review | Approved | |
| Aug 13, 1999 | Supplement 30Labeling · Standard review | Approved | None posted |
| Jul 14, 1997 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Jan 7, 1997 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| May 23, 1995 | Supplement 26Labeling · Standard review | Approved | None posted |
| May 4, 1994 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Jan 13, 1994 | Supplement 24Labeling · Standard review | Approved | None posted |
| Jan 13, 1993 | Supplement 23Labeling · Standard review | Approved | None posted |
| Oct 10, 1989 | Supplement 22Labeling | Approved | None posted |
| Sep 12, 1989 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Dec 9, 1988 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Feb 1, 1988 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Sep 30, 1987 | Supplement 15Labeling | Approved | None posted |
| Aug 26, 1987 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Aug 12, 1985 | Supplement 18Labeling | Approved | None posted |
| Feb 7, 1984 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Feb 7, 1984 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Jul 15, 1983 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Jul 15, 1983 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Feb 18, 1983 | Supplement 14Labeling | Approved | None posted |
| Dec 2, 1982 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Dec 2, 1982 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Jan 3, 1980 | Supplement 8Labeling | Approved | None posted |
| Apr 25, 1978 | Supplement 5Labeling | Approved | None posted |
| Apr 25, 1978 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| May 11, 1977 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Nov 27, 1973 | Original applicationNew molecular entity · Standard review | 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
