Treats Candida urinary tract infections, peritonitis, and systemic Candida infections…. NDA 20090, held by Pfizer. Fluconazole.
As of Nov 13, 2026, NDA 20090 (Diflucan), held by Pfizer, was first approved by FDA on Dec 23, 1993, with 36 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Fluconazole is indicated for the treatment of: 1. Vaginal candidiasis (vaginal yeast infections due to Candida ). 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 3. Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 23, 1993 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Diflucan50MG/5ML · for suspension;oral | Fluconazole | RxReference drug |
| Diflucan200MG/5ML · for suspension;oral | Fluconazole | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 12, 2024 | Supplement 53Labeling · Standard review | Approved | |
| Jul 12, 2023 | Supplement 55Labeling · Standard review | Approved | |
| Jan 17, 2023 | Supplement 54Labeling · Standard review | Approved | |
| Mar 9, 2022 | Supplement 52Labeling · Standard review | Approved | |
| Oct 25, 2021 | Supplement 51Labeling · Standard review | Approved | |
| Sep 8, 2020 | Supplement 50Labeling · Standard review | Approved | |
| Feb 7, 2019 | Supplement 47Labeling · Standard review | Approved | |
| Mar 9, 2018 | Supplement 46Labeling · Standard review | Approved | |
| Jan 22, 2018 | Supplement 49Labeling · Standard review | Approved | |
| Oct 27, 2017 | Supplement 48Labeling · Standard review | Approved | |
| Oct 30, 2014 | Supplement 44Labeling · Standard review | Approved | |
| Jul 28, 2014 | Supplement 43Manufacturing | Approved | None posted |
| Mar 24, 2014 | Supplement 42Labeling · Standard review | Approved | |
| Jan 7, 2014 | Supplement 41Manufacturing | Approved | None posted |
| Sep 13, 2013 | Supplement 40Labeling · Standard review | Approved | |
| Nov 16, 2011 | Supplement 38Labeling · Standard review | Approved | |
| Jun 6, 2011 | Supplement 34Labeling | Approved | |
| Apr 26, 2011 | Supplement 36Labeling | Approved | |
| Aug 5, 2010 | Supplement 31Labeling | Approved | |
| Mar 31, 2008 | Supplement 22Labeling · Standard review | Approved | |
| Oct 7, 2004 | Supplement 17Labeling · Standard review | Approved | |
| Oct 7, 2004 | Supplement 14Labeling · Standard review | Approved | |
| Oct 7, 2004 | Supplement 12Labeling · Standard review | Approved | |
| Mar 24, 2004 | Supplement 19Labeling · Standard review | Approved | |
| Aug 7, 2002 | Supplement 15Labeling · Standard review | Approved | |
| Mar 5, 2001 | Supplement 13Manufacturing | Approved | None posted |
| Feb 22, 1999 | Supplement 11Labeling · Standard review | Approved | None posted |
| Aug 5, 1997 | Supplement 10Labeling · Standard review | Approved | None posted |
| Feb 19, 1997 | Supplement 9Labeling · Standard review | Approved | None posted |
| Aug 6, 1996 | Supplement 8Labeling · Standard review | Approved | None posted |
| Jul 23, 1996 | Supplement 6Labeling · Standard review | Approved | None posted |
| Dec 22, 1995 | Supplement 5Manufacturing | Approved | None posted |
| Feb 21, 1995 | Supplement 4Labeling · Standard review | Approved | None posted |
| Feb 21, 1995 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jun 30, 1994 | Supplement 2Labeling · Standard review | Approved | None posted |
| Mar 22, 1994 | Supplement 1Labeling · Standard review | Approved | None posted |
| Dec 23, 1993 | Original applicationNew dosage form · 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
