Data updated: May 26, 2026
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (fluconazole)
Cytochrome P450 2C19 Inhibitors
Infectious Disease
Approved 2004-07-29
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is indicated for the treatment of Vaginal Candidiasis; Oropharyngeal Candidiasis; Esophageal Candidiasis; Candida Urinary Tract Infection; Peritonitis; Candidemia; Disseminated Candidiasis; Pneumonia; Cryptococcal Meningitis; Candidiasis.
Source: FDA Label • Hikma
7
Indications
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Phase 3 Trials
21
Years on Market
Details
- Status
- Prescription
- First Approved
- 2004-07-29
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Approval History
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Original
New Indication
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Label Update
112 FDA actions from 2004 to 2026
Jan 2026 SUPPL
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Jan 2012 ORIGINAL
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What FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Treats
10 indicationsFLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is approved for 10 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Vaginal Candidiasis
- Oropharyngeal Candidiasis
- Esophageal Candidiasis
- Candida Urinary Tract Infection
- Peritonitis
- Candidemia
- Disseminated Candidiasis
- Pneumonia
Source: FDA Label
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Competitive Set
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Clinical Trial Registry
81 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05076409 results posted | 1346-0017 2021-003389-10 | Ph 1 | completed | A Study in Healthy Men to Test How Fluconazole Influences the Amount of BI 425809 in the Blood |
| NCT03945448 ACACIA | ST/225/2018 | Ph 2, Ph 3 | recruiting | Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia |
| NCT07341672 | HEC73543-AML-105 | Ph 1 | not yet recruiting | A Single-center, Randomized, Open-label, Parallel-design Clinical Study to Evaluate the Pharmacokinetic Effects of Itraconazole, Fluconazole or Efavirenz on a Single Dose of Clifutinib in Healthy Participants |
| NCT05421858 | FMGX-CS-301 2022-500455-23-00 | Ph 3 | recruiting | A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis. |
| NCT02997059 AscaMC | 2006_27 2008-000717-30, PHRC2006R/1903 | Ph 2 | completed | Effect of Fluconazole on the Levels of ASCA After Surgical Resection for Crohn's Disease. |
| NCT04368559 ReSPECT | CD101.IV.3.08 2017-004981-85 | Ph 3 | completed | Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation |
| NCT07439250 | 27768 J3M-MC-JZQM | Ph 1 | completed | A Study of Olomorasib (LY3537982) in Healthy Participants |
| NCT07395024 | 3082-CL-0102 | Ph 1 | recruiting | A Study to Learn How Fluconazole, Carbamazepine and Itraconazole Affect How the Body Processes ASP3082 in Healthy Adults |
| NCT05178862 MARIO | SCY-078-302 MSG-20 | Ph 3 | terminated | A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole |
| NCT06274554 FUN-CD | 23-11026746 | Ph 3 | recruiting | Testing the Role of Anti-fungal Therapy in Improving the Response to Therapies for Crohn's Disease |
| NCT02145832 TINN | C11-11 2012-001916-41 | Ph 2, Ph 3 | completed | Fluconazole Versus Micafungin in Neonates With Candidiasis |
| NCT06847464 | EDP 323-005 | Ph 1 | completed | A Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, Quinidine and Fluconazole on the Pharmacokinetics and Safety of EDP-323. |
| NCT06345794 | DCE853103 J5C-MC-FOAG, DCE853103 | Ph 1 | completed | A Study to Assess LY4100511 (DC-853) in Healthy Adult Participants |
| NCT06922344 | 84/DME/KMC | Ph 4 | recruiting | Comparison of Efficacy of Oral Fluconazole Versus Oral Itraconazole in the Treatment of Pityriasis Versicolor |
| NCT06822166 | ET-26-HCL-CP-006 | Ph 1 | completed | Drug Interactions Trial of Methoxyethyl Etomidate Hydrochloride |
| NCT03135106 | CR108299 2017-000117-23, 42756493EDI1007 | Ph 1 | completed | A Study to Evaluate the Effect of Fluconazole and Itraconazole on Erdafitinib Pharmacokinetics in Healthy Adult Participants |
| NCT06770530 IMPACT | 2023-506226-36-00 | Ph 4 | recruiting | Introduction of Mycotic Prophylaxis At Cystectomy Trial. |
| NCT06709196 REINFORCE | 2024-514312-27-00 2024-514312-27-00 | Ph 4 | recruiting | Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis |
| NCT01058174 TENPIN | 9463-EC-0001 2008-005214-49 | Ph 3 | completed | Liver Transplant European Study Into the Prevention of Fungal Infection |
| NCT04551963 results posted | BGB-3111-113 | Ph 1 | completed | Interaction Study of Zanubrutinib With Moderate and Strong CYP3A Inhibitors in Participants With B-Cell Malignancies |
| NCT01503515 results posted | ACCL1131 NCI-2012-00102, CDR0000721415 | Ph 3 | completed | Caspofungin Acetate, Fluconazole, or Voriconazole in Preventing Fungal Infections in Patients Following Donor Stem Cell Transplant |
| NCT04495608 FLUCOLITH | 69HCL20_0071 2020-003011-97 | Ph 2 | completed | Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Fluconazole in Hypercalcicuric Patients With Increased 1.25(OH) 2D Levels |
| NCT02244606 results posted | SCY-078-202 | Ph 2 | completed | Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis |
| NCT02765256 Holiday results posted | 823635 | Ph 2 | completed | Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease |
| NCT04038008 | PTL-P3-438 (v. 1.0 2019/07/12) | Ph 1 | completed | Single Dose Crossover Comparative Bioavailability Study of Two Formulations of Fluconazole 200 mg in Healthy Adult Subjects Under Fasting Conditions |
| NCT03028103 results posted | EZH-105 | Ph 1 | completed | Open-Label, Multicenter, Two-Part, Phase 1 Study to Characterize Effects of a Moderate CYP3A Inhibitor on PK of Tazemetostat, Effects of Tazemetostat on PK of CYP2C8 and CYP2C19 Substrates, and Effect of Increased Gastric pH on PK of Tazemetostat in B-cell Lymphoma or Advanced Solid Tumor Patients |
| NCT05367089 | NL73974.068.21 | Ph 3 | recruiting | The Effect of Medical Grade Honey Formulation (L-Mesitran) Administration on Recurrent Vulvovaginal Candidiasis Symptoms |
| NCT05862714 | CMHAbbottabad1 | Ph 1 | completed | Comparison of Efficacy of Single Oral Dose Fluconazole and Itraconazole in Patients With Pityriasis Versicolor |
| NCT05848492 | FluconazolePreterm1 | Ph 3 | completed | Efficacy of Prophylactic Fluconazole Therapy in Preterm and Very Low Birth Weight Neonates in Preventing Invasive Fungal Infection. |
| NCT03667690 ReSTORE results posted | CD101.IV.3.05 | Ph 3 | completed | Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis |
| NCT04933682 | ALXN2050-HV-105 | Ph 1 | completed | Drug Interaction Study of ALXN2050 With Fluconazole and Rifampin in Healthy Adult Participants |
| NCT05478772 | CP543.1015 | Ph 1 | completed | Study to Evaluate Multiple Doses of Fluconazole, a CYP3A4 and CYP2C9 Inhibitor, on the Pharmacokinetics of CTP-543 in Healthy Subjects |
| NCT04464577 | CV018-014 | Ph 1 | withdrawn | A Study to Evaluate the Effect of Fluconazole, Bupropion, or Itraconazole on the Drug Levels and Safety of BMS-986235 |
| NCT03476317 Holiday results posted | 17-014343 5K23DK109136-02 | Ph 2 | completed | Pilot Study of Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease |
| NCT05140096 | ACE-HV-114 | Ph 1 | completed | A Study to Evaluate the Effect of Pharmacokinetics (PK) of Acalabrutinib and Its Active Metabolite (ACP-5862) When Administered Alone and With Moderate CYP3A4 Inhibitors Fluconazole or Isavuconazole in Healthy Adult Participants |
| NCT04702464 | FEDR-CP-004 U1111-1261-2721 | Ph 1 | completed | A Study to Evaluate the Effect of a Dual CYP2C19 and CYP3A4 Inhibitor, Fluconazole, on the Pharmacokinetics of Fedratinib in Healthy Adult Subjects |
| NCT00885703 results posted | A5225 (HiFLAC) 10149, ACTG A5225 | Ph 1, Ph 2 | completed | High-Dose Fluconazole for the Treatment of Cryptococcal Meningitis in HIV-Infected Individuals |
| NCT01562132 SToP-Crypto results posted | 1307012426 R21NS077858-01 | Ph 2 | terminated | Safety Study of Fluconazole in Combination With Flucytosine for the Treatment of Early Cryptococcal Infection |
| NCT03253094 DOVE results posted | SCY-078-204 | Ph 2 | completed | Dose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis |
| NCT01806623 results posted | A0561023 | Ph 3 | completed | The Study Of Fluconazole For Vulvovaginal Candidiasis |
| NCT04871724 | EDP 938-007 | Ph 1 | completed | Drug-Drug Interaction Study Between Fluconazole and EDP-938 in Healthy Subjects |
| NCT01307579 results posted | ACCL0933 NCI-2011-02640, CDR0000695748 | Ph 3 | completed | Caspofungin Versus Fluconazole in Preventing Invasive Fungal Infections (IFI) in Patients Undergoing Chemotherapy for Acute Myeloid Leukemia |
| NCT01950507 | 130197 13-H-0197 | Ph 1 | terminated | Evaluation of Budesonide and How It Interacts With Antifungal Drugs in People With Gastrointestinal Graft-Versus-Host Disease |
| NCT02222922 results posted | B7661001 2014-003296-36 | Ph 1 | completed | A Study Of PF-06647020 For Adult Patients With Advanced Solid Tumors |
| NCT02734862 STRIVE results posted | CD101.IV.2.03 2015-005599-51 | Ph 2 | completed | CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension |
| NCT02180100 results posted | PKUSH-GNY-2013-01 | Ph 4 | completed | Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe Vulvovaginal Candidiasis |
| NCT02733432 | CD101.TP.2.01 | Ph 2 | completed | RADIANT: CD101 vs Standard of Care in Subjects With Acute Vaginal Yeast Infections |
| NCT03002012 C-ASSERT results posted | U01AI125003 U01AI125003, 33238 | Ph 3 | terminated | Cryptococcal Antigen Screening Plus Sertraline |
| NCT01535469 ORCAS | HS1254 U01GH000517 | Ph 4 | completed | Operational Research for Cryptococcal Antigen Screening |
| NCT04201054 FLUC | IMIMFTCL/FLUC | Ph 1 | completed | Generation of Biological Samples Positive to Fluconazole for Anti-Doping Control |
Showing 50 of 81 trials
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER FDA Label Details
Indications & Usage
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is indicated for the treatment of Vaginal Candidiasis; Oropharyngeal Candidiasis; Esophageal Candidiasis; Candida Urinary Tract Infection; Peritonitis; Candidemia; Disseminated Candidiasis; Pneumonia; Cryptococcal Meningitis; Candidiasis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.