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Details for Generic Name: ketoconazole

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Summary for Generic Name: ketoconazole

Drug Master File Entries: see list15
Suppliers: see list6
Therapeutic Class:Antifungals

Pharmacology for Ingredient: ketoconazole

Clinical Trials for: ketoconazole

Phase I Study to Assess the Effect on Healthy Male Volunteers of Ketoconazole on the Pharmacokinetics of a Single Dose of AZD5069 Administered Orally.
Status: Completed Condition: Asthma,; Pharmacokinetics,; Cmax,; Tmax,; λz,; AUC,; Ketoconazole,; Metabolite

Ketoconazole Foam 2% for the Treatment of Versicolor
Status: Completed Condition: Tinea Versicolor

Use of Low Dose Ketoconazole in Prostate Cancer That Does Not Respond to Hormone Therapy and Prior Chemotherapy
Status: Active, not recruiting Condition: Prostate Cancer

Drug Interaction Study of the Effect of Ketoconazole at Steady State on the Pharmacokinetics of a Single Dose of Isavuconazole in Healthy Adult Subjects
Status: Completed Condition: Pharmacokinetics of Isavuconazole; Pharmacokinetics of Ketoconazole; Healthy Adult Volunteers

VEG113971: An Open-Label Study of the Effects of Ketoconazole or Esomeprazole on Pazopanib PK
Status: Completed Condition: Cancer

Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole
Status: Completed Condition: Healthy

Buprenorphine Accumulation and Description of Its Metabolites During Co-Medication of Buprenorphine Transdermal System (BTDS) and Ketoconazole
Status: Completed Condition: Healthy

Ketoconazole and Dexamethasone in Prostate Cancer
Status: Active, not recruiting Condition: Prostate Cancer

Study to Evaluate the Effect of Rifampicin, Ketoconazole, and Omeprazole on the Pharmacokinetics of Sativex
Status: Completed Condition: Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a Known Inducer of CYP3A4; Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a Potent Inhibitor of CYP3A4; Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a CYP2C19 Inhibitor.

Drug-drug Interaction Study (CKD-501, Ketoconazole)
Status: Completed Condition: Type 2 Diabetes Mellitus

Courtesy of
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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mcneil Cons
SHAMPOO;TOPICAL020310Oct 10, 1997OTCYes5,456,851<disabled><disabled>
Aaipharma Llc
TABLET;ORAL075341Jul 27, 1999DISCNNo<disabled><disabled>
CREAM;TOPICAL075581Apr 25, 2000RXYes<disabled><disabled>
Aqua Pharms
GEL;TOPICAL021946Jul 28, 2006RXYes7,179,475<disabled>Y<disabled>
Perrigo Israel
AEROSOL, FOAM;TOPICAL091550Aug 25, 2011RXNo<disabled><disabled>
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