Oropharyngeal Candidiasis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2019-07-16FDA Approved: FLUCONAZOLE — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for Fluconazole from Zydus Lifesciences Limited, resulting in regulatory approval of this generic pr…
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FDA approval · 2018-05-25FDA Approved: NYSTATIN — Original Application (Viona Pharmaceuticals Inc)
FDA approved NYSTATIN as an Original Application (ANDA 207767) for a generic nystatin product by Viona Pharmaceuticals Inc.
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FDA approval · 2018-05-21FDA Approved: NYSTATIN — Original Application (Leading Pharma, LLC)
The FDA has approved an original ANDA for NYSTATIN from Leading Pharma, LLC.
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CLINICAL_TRIALS research · 2017-10-12Clinical Trial Update: A Comparative Clinical Trial to Evaluate the Safety and Clinical Equivalence of Clotrimazole Troche/Lozenges USP, 10mg (Unique Pharmaceutical Laboratories, India) With Clotrimazole Troche 10mg (Roxane Laboratories Inc., USA) in Subjects With Oropharyngeal Candidiasis. [Phase 3]
Phase 3 clinical trial comparing safety and clinical equivalence of two clotrimazole troche/lozenge formulations for oropharyngeal candidias…
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FDA approval · 2017-06-08FDA Approved: NYSTATIN — Original Application (Zydus Lifesciences Limited)
FDA approves the original application for Nystatin from Zydus Lifesciences Limited.
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CLINICAL_TRIALS trial_result · 2015-08-17Clinical Trial Update: A Study Of The Safety, Tolerability And Effective Of Voriconazole For The Treatment Of Serious Candida Infection And Candida Infection Of The Throat In Pediatric Patients [Phase 3]
A Phase 3 pediatric trial of voriconazole for serious Candida infections, including oropharyngeal candidiasis, was terminated; results were …
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FDA approval · 2015-03-19FDA Approved: FLUCONAZOLE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for Fluconazole from Hikma Pharmaceuticals USA Inc., updating the regulatory approval of this pr…
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FDA approval · 2015-03-14FDA Approved: FLUCONAZOLE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved a supplemental application for fluconazole from Glenmark Pharmaceuticals Inc., USA.
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FDA approval · 2015-02-27FDA Approved: FLUCONAZOLE — Supplemental Application (Rising Pharma Holdings, Inc.)
The FDA approved a supplemental application for fluconazole from Rising Pharma Holdings, Inc. for a generic fluconazole product.
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CLINICAL_TRIALS trial_result · 2015-02-16Clinical Trial Update: Gentian Violet Vs. Nystatin Oral Suspension for Treatment of Oropharyngeal Candidiasis [Phase 3]
Phase 3 trial comparing Gentian Violet with Nystatin oral suspension for treating oropharyngeal candidiasis in HIV-1 infected individuals co…
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CLINICAL_TRIALS trial_result · 2014-08-20Clinical Trial Update: Study of Mycamine® in Infants and Toddlers With Fungal Infections to Evaluate Safety and Blood Levels of the Drug [Phase 1]
A Phase 1 study evaluating the safety and drug blood levels of micafungin (Mycamine) in infants and toddlers with invasive candidiasis, esop…
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CLINICAL_TRIALS trial_result · 2014-08-20Clinical Trial Update: Trial of Two Dosing Regimens of Micafungin Versus Caspofungin for the Treatment of Esophageal Candidiasis [Phase 3]
A Phase 3 trial comparing two dosing regimens of micafungin to caspofungin for esophageal candidiasis has completed.
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CLINICAL_TRIALS trial_result · 2014-07-14Clinical Trial Update: Clotrimazole vs. Mycelex® in Patients With Human Insufficiency Virus (HIV) Infection for the Treatment of Oropharyngeal Candidiasis [Phase 3]
Phase 3 trial comparing clotrimazole (generic) versus Mycelex brand of clotrimazole for treating oropharyngeal candidiasis in HIV-infected p…
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FDA approval · 2014-03-24FDA Approved: FLUCONAZOLE IN SODIUM CHLORIDE — Supplemental Application (Hospira, Inc.)
The FDA approved Hospira's supplemental application for Fluconazole in Sodium Chloride, an intravenous formulation of fluconazole.
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CLINICAL_TRIALS trial_result · 2013-08-29Clinical Trial Update: Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients [Phase 3]
Phase 3 trial results evaluating the efficacy and safety of Miconazole Lauriad for treating oropharyngeal candidiasis in HIV-infected patien…
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FDA approval · 2013-03-05FDA Approved: ORAVIG — Supplemental Application (Galt Pharmaceuticals, LLC)
FDA approved a supplemental application for ORAVIG (miconazole) submitted by Galt Pharmaceuticals, LLC.
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FDA approval · 2012-03-14FDA Approved: FLUCONAZOLE — Supplemental Application (Hospira, Inc)
The FDA approved a supplemental application for fluconazole submitted by Hospira, Inc., authorizing changes to the product under the ANDA.
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FDA approval · 2012-01-30FDA Approved: FLUCONAZOLE — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approves Hikma Pharmaceuticals USA Inc.'s generic fluconazole under Original Application (ANDA 078698). The approval covers multiple fun…
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FDA approval · 2012-01-25FDA Approved: FLUCONAZOLE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for fluconazole submitted by Hikma Pharmaceuticals USA Inc.
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FDA approval · 2011-10-13FDA Approved: FLUCONAZOLE — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application for fluconazole by Rising Pharma Holdings, Inc., authorizing an updated generic product under the AN…
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FDA approval · 2011-04-08FDA Approved: ORAVIG — Supplemental Application (Galt Pharmaceuticals, LLC)
The FDA approved a supplemental application for ORAVIG (miconazole) from Galt Pharmaceuticals, LLC. This action updates/expands the product'…
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FDA approval · 2011-03-07FDA Approved: FLUCONAZOLE — Original Application (ANI Pharmaceuticals, Inc.)
ANI Pharmaceuticals received FDA approval for an original generic application of fluconazole.
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FDA approval · 2010-04-16FDA Approved: ORAVIG — Original Application (Galt Pharmaceuticals, LLC)
FDA approves ORAVIG (miconazole) under an original NDA from Galt Pharmaceuticals, LLC for the treatment of oropharyngeal candidiasis.
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FDA approval · 2009-09-18FDA Approved: FLUCONAZOLE — Original Application (Rising Pharma Holdings, Inc.)
FDA approved the original application for fluconazole from Rising Pharma Holdings, Inc., enabling the generic antifungal to enter the market…
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CLINICAL_TRIALS trial_result · 2008-05-07Clinical Trial Update: Single Dose Versus Two Weeks Course of Fluconazole in the Treatment of Oropharyngeal Candidiasis in HIV Infected Individuals in Tanzania [Phase 4]
A Phase 4 trial in Tanzania compared single-dose versus two-week fluconazole for treating oropharyngeal candidiasis in HIV-infected patients…