For metastatic testicular tumors. NDA 18057, held by Hq Spclt Pharma. Cisplatin.
As of Nov 13, 2026, NDA 18057 (Platinol, Cisplatin, Platinol-Aq), held by Hq Spclt Pharma, was first approved by FDA on Dec 19, 1978, with 66 approved supplements and 0 published complete response letters.
INDICATIONS Cisplatin Injection is indicated as therapy to be employed as follows: Metastatic Testicular Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors who have already received appropriate surgical and/or radiotherapeutic procedures. Metastatic Ovarian Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic ovarian tumors who have already received appropriate surgical and/or radiotherapeutic procedures. An established combination consists of Cisplatin Injection and cyclophosphamide.
| Apr 22, 1993 | Supplement 61Efficacy (new indication or use) | Approved | None posted |
| Dec 29, 1981 | Supplement 12Efficacy (new indication or use) | Approved | None posted |
| Dec 19, 1978 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Mar 24, 2022 | Supplement 92Labeling · Standard review | Approved | |
| Feb 22, 2019 | Supplement 89Manufacturing | Approved | |
| Jan 19, 2017 | Supplement 86Manufacturing · Standard review | Approved | None posted |
| Oct 6, 2015 | Supplement 85Manufacturing · Standard review | Approved | None posted |
| Mar 3, 2015 | Supplement 84Manufacturing · Standard review | Approved | None posted |
| Feb 26, 2015 | Supplement 83Labeling · Standard review | Approved | |
| Feb 6, 2014 | Supplement 82Manufacturing · Standard review | Approved | None posted |
| Dec 29, 2011 | Supplement 81Labeling | Approved | |
| Aug 26, 2011 | Supplement 80Labeling | Approved | |
| Sep 2, 2010 | Supplement 79Labeling · Standard review | Approved | |
| Nov 8, 2002 | Supplement 76Labeling · Standard review | Approved | |
| Jan 16, 2001 | Supplement 75Manufacturing · Standard review | Approved | None posted |
| Sep 13, 2000 | Supplement 74Manufacturing · Standard review | Approved | None posted |
| May 5, 1999 | Supplement 72Labeling · Standard review | Approved | None posted |
| Apr 18, 1996 | Supplement 66Manufacturing · Standard review | Approved | None posted |
| Dec 13, 1995 | Supplement 63Manufacturing · Standard review | Approved | None posted |
| Dec 4, 1995 | Supplement 64Manufacturing · Standard review | Approved | None posted |
| Aug 9, 1995 | Supplement 65Labeling · Standard review | Approved | None posted |
| May 17, 1993 | Supplement 62Labeling · Standard review | Approved | None posted |
| Apr 22, 1993 | Supplement 61Efficacy (new indication or use) | Approved | None posted |
| Mar 25, 1993 | Supplement 60Labeling · Standard review | Approved | None posted |
| Jul 27, 1992 | Supplement 56Labeling | Approved | None posted |
| Nov 27, 1991 | Supplement 53Manufacturing · Standard review | Approved | None posted |
| Nov 1, 1991 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| Jul 11, 1991 | Supplement 57Manufacturing · Standard review | Approved | None posted |
| Dec 11, 1990 | Supplement 51Labeling | Approved | None posted |
| Sep 27, 1990 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| May 29, 1990 | Supplement 58Manufacturing · Standard review | Approved | None posted |
| Apr 4, 1990 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Mar 2, 1989 | Supplement 49Labeling | Approved | None posted |
| Nov 8, 1988 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| May 5, 1988 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Feb 11, 1988 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Jan 13, 1988 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Jan 12, 1988 | Supplement 50Manufacturing · Standard review | Approved | None posted |
| Jun 8, 1987 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Apr 10, 1987 | Supplement 46Labeling | Approved | None posted |
| Mar 23, 1987 | Supplement 43Labeling | Approved | None posted |
| Mar 5, 1987 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Nov 6, 1986 | Supplement 42Labeling | Approved | None posted |
| Aug 26, 1986 | Supplement 39Labeling | Approved | None posted |
| Aug 19, 1986 | Supplement 41Labeling | Approved | None posted |
| May 2, 1986 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Jan 22, 1986 | Supplement 38Labeling | Approved | None posted |
| Sep 16, 1985 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Aug 23, 1985 | Supplement 22Labeling | Approved | None posted |
| Jul 3, 1985 | Supplement 32Labeling | Approved | None posted |
| Mar 5, 1985 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Mar 5, 1985 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Jul 18, 1984 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Apr 4, 1984 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Feb 27, 1984 | Supplement 20Labeling | Approved | None posted |
| Oct 31, 1983 | Supplement 26Labeling | Approved | None posted |
| Jan 13, 1983 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Jun 10, 1982 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Dec 29, 1981 | Supplement 12Efficacy (new indication or use) | Approved | None posted |
| Mar 12, 1981 | Supplement 11Labeling | Approved | None posted |
| Jan 22, 1981 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Sep 16, 1980 | Supplement 9Labeling | Approved | None posted |
| Jul 4, 1980 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Feb 26, 1980 | Supplement 6Labeling | Approved | None posted |
| Jan 31, 1980 | Supplement 5Labeling | Approved | None posted |
| Jan 31, 1980 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Dec 18, 1979 | Supplement 2Labeling | Approved | None posted |
| Dec 5, 1979 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Sep 11, 1979 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Dec 19, 1978 | 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
