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Details for Generic Name: itraconazole

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Summary for Generic Name: itraconazole

Drug Master File Entries: see list15
Suppliers: see list5
Therapeutic Class:Antifungals

Pharmacology for Ingredient: itraconazole

Clinical Trials for: itraconazole

Itraconazole Tablets Vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail.
Status: Completed Condition: Onychomycosis, Toenail Onychomychosis, Toenail Fungus.

The Relationship of Defeverscence and Itraconazole Plasma Level Study in Immunocompromised Participants
Status: Completed Condition: Hematologic Neoplasms; Neutropenia; Fever

A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of Alisertib in Patients With Advanced Solid Tumors or Relapsed/Refractory Lymphoma
Status: Recruiting Condition: Advanced Solid Tumors; Relapsed/Refractory Lymphoma

A Study of Empirical Antifungal Therapy With Itraconazole
Status: Completed Condition: Neutropenia

A Study to Assess the Interaction Between ASP1707 and Itraconazole in Healthy Female Subjects
Status: Completed Condition: Pharmacokinetics; DDI (Drug-Drug Interaction); Healthy Subjects

A Pilot Trial of Itraconazole Pharmacokinetics in Patients With Metastatic Breast Cancer
Status: Active, not recruiting Condition: Breast Neoplasms; Neoplasm Metastasis

A Randomized Phase II Study of Itraconazole and Pemetrexed in Patients With Previously Treated Non-Squamous Non-Small Cell Lung Cancer
Status: Terminated Condition: Recurrent Non Small Cell Lung Cancer

Scoring Clinical Index For Onychomycosis in Toenail Onychomycosis Treating With Itraconazole Capsules
Status: Completed Condition: Onychomycosis, Toe

Study to Determine the Effect of Itraconazole on the Pharmacokinetics of Rilapladib (SB659032) in Healthy Volunteers
Status: Not yet recruiting Condition: Alzheimer's Disease

A Two-dose Level Clinical Trial of Itraconazole in Patients With Metastatic Prostate Cancer Who Have Had Disease Progression While on Hormonal Therapy
Status: Completed Condition: Prostate Cancer

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms
CAPSULE;ORAL020083Sep 11, 1992RXYes5,633,015<disabled><disabled>
Merz Pharms
TABLET;ORAL022484Apr 29, 2010RXYes6,509,038<disabled>Y<disabled>
Merz Pharms
TABLET;ORAL022484Apr 29, 2010RXYes7,081,255<disabled>Y<disabled>
Mylan Pharms Inc
CAPSULE;ORAL200463Jul 20, 2012RXNo<disabled><disabled>
Janssen Pharms
INJECTABLE;INJECTION020966Mar 30, 1999DISCNNo6,407,079<disabled><disabled>
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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