Treats wound sepsis. NDA 17381, held by King Pharms LLC. Silver Sulfadiazine.
As of Nov 13, 2026, NDA 17381 (Silvadene), held by King Pharms LLC, was first approved by FDA on Nov 26, 1973, with 40 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE SILVADENE Cream 1% (silver sulfadiazine) is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second- and third-degree burns.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 26, 1973 | Original applicationNew active ingredient · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Silvadene1% · cream;topical | Silver Sulfadiazine | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 1, 2016 | Supplement 53Labeling · Standard review | Approved | |
| Apr 30, 2015 | Supplement 52Manufacturing · Priority review | Approved | None posted |
| Mar 6, 2013 | Supplement 50Labeling · Standard review | Approved | |
| Nov 13, 2012 | Supplement 49Manufacturing · Priority review | Approved | None posted |
| Jan 29, 2004 | Supplement 41Labeling · Standard review | Approved | |
| Sep 27, 2001 | Supplement 40Manufacturing · Priority review | Approved | None posted |
| Nov 4, 1993 | Supplement 39Manufacturing · Priority review | Approved | None posted |
| Dec 7, 1992 | Supplement 38Manufacturing · Priority review | Approved | None posted |
| Oct 5, 1992 | Supplement 34Labeling | Approved | None posted |
| Feb 27, 1992 | Supplement 37Manufacturing · Priority review | Approved | None posted |
| May 13, 1991 | Supplement 36Manufacturing · Priority review | Approved | None posted |
| Jan 29, 1991 | Supplement 35Manufacturing · Priority review | Approved | None posted |
| Nov 14, 1988 | Supplement 32Labeling | Approved | None posted |
| Oct 29, 1987 | Supplement 31Manufacturing · Priority review | Approved | None posted |
| Nov 28, 1986 | Supplement 30Labeling | Approved | None posted |
| Nov 15, 1985 | Supplement 29Manufacturing · Priority review | Approved | None posted |
| Jun 12, 1984 | Supplement 28Manufacturing · Priority review | Approved | None posted |
| May 31, 1984 | Supplement 27Manufacturing · Priority review | Approved | None posted |
| Dec 6, 1982 | Supplement 25Manufacturing · Priority review | Approved | None posted |
| Dec 6, 1982 | Supplement 24Manufacturing · Priority review | Approved | None posted |
| Sep 15, 1982 | Supplement 21Manufacturing · Priority review | Approved | None posted |
| Sep 10, 1982 | Supplement 23Manufacturing · Priority review | Approved | None posted |
| Apr 19, 1982 | Supplement 22Manufacturing · Priority review | Approved | None posted |
| Apr 19, 1982 | Supplement 20Manufacturing · Priority review | Approved | None posted |
| Aug 28, 1981 | Supplement 18Manufacturing · Priority review | Approved | None posted |
| Mar 4, 1981 | Supplement 19Manufacturing · Priority review | Approved | None posted |
| Jun 26, 1980 | Supplement 17Manufacturing · Priority review | Approved | None posted |
| Nov 26, 1979 | Supplement 16Manufacturing · Priority review | Approved | None posted |
| Jul 6, 1979 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Jun 14, 1979 | Supplement 15Labeling | Approved | None posted |
| Apr 17, 1979 | Supplement 12Manufacturing · Priority review | Approved | None posted |
| Sep 28, 1978 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Jul 24, 1978 | Supplement 11Labeling | Approved | None posted |
| Jan 31, 1978 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| May 24, 1977 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| May 2, 1977 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Apr 6, 1977 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Jan 24, 1977 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Jul 17, 1975 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Nov 11, 1974 | Supplement 1Labeling | Approved | None posted |
| Nov 26, 1973 | Original applicationNew active ingredient · Priority 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
