NDA 18025, held by Intl Medication. Furosemide.
As of Nov 13, 2026, NDA 18025 (Furosemide), held by Intl Medication, was first approved by FDA on Jan 10, 1979, with 16 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 10, 1979 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Furosemide10MG/ML ยท injectable;injection | Furosemide | Discontinued |
| Oct 21, 2002 | Supplement 34Manufacturing | Approved | None posted |
| Sep 17, 1999 | Supplement 33Labeling | Approved | None posted |
| Mar 5, 1998 | Supplement 32Labeling | Approved | None posted |
| Jan 14, 1998 | Supplement 28Manufacturing | Approved | None posted |
| Sep 19, 1995 | Supplement 31Manufacturing | Approved | None posted |
| Jun 17, 1994 | Supplement 29Manufacturing | Approved | None posted |
| Jun 7, 1994 | Supplement 30Manufacturing | Approved | None posted |
| Oct 29, 1993 | Supplement 27Manufacturing | Approved | None posted |
| Dec 17, 1992 | Supplement 26Manufacturing | Approved | None posted |
| Apr 29, 1992 | Supplement 23Labeling | Approved | None posted |
| Mar 17, 1992 | Supplement 25Labeling | Approved | None posted |
| Mar 17, 1992 | Supplement 24Labeling | Approved | None posted |
| Mar 15, 1991 | Supplement 22Labeling | Approved | None posted |
| May 1, 1987 | Supplement 18Manufacturing | Approved | None posted |
| Jun 13, 1985 | Supplement 11Manufacturing | Approved | None posted |
| May 8, 1985 | Supplement 10Manufacturing | Approved | None posted |
| Jan 10, 1979 | 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
