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Fluconazoleis the generic ingredient in eight branded drugs marketed by Pfizer, Aurobindo Pharma Ltd, Hikma, Ivax Sub Teva Pharms, Sun Pharm Inds Ltd, Taro Pharm Inds, Hikma Farmaceutica, Hospira, Mylan Labs Ltd, Woodward, Baxter Hlthcare Corp, Dr Reddys, Fresenius Kabi Usa, West-ward Pharms Int, Baxter Hlthcare, Inforlife, Ani Pharms Inc, Aurobindo Pharma, Chartwell, Dr Reddys Labs Inc, Gedeon Richter Usa, Glenmark Generics, Mylan, Mylan Pharms Inc, Pliva, Ranbaxy Labs Ltd, Roxane, Taro, Teva, Unique Pharm Labs, and Zydus Pharms, and is included in forty-three NDAs. Additional information is available in the individual branded drug profile pages.
There are twenty-three drug master file entries for fluconazole. Forty-one suppliers are listed for this compound. There are five tentative approvals for this compound.
Summary for fluconazole
|Drug Master File Entries:||23|
|Finished Product Suppliers / Packagers:||41|
|Raw Ingredient (Bulk) Api Vendors:||133|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price trends for fluconazole|
|Drug Sales Revenues:||Drug sales revenues for fluconazole|
|What excipients (inactive ingredients) are in fluconazole?||fluconazole excipients list|
|DailyMed Link:||fluconazole at DailyMed|
Recent Clinical Trials for fluconazole
Identify potential brand extensions & 505(b)(2) entrants
|George R Thompson||Phase 2|
|Mayne Pharma International Pty Ltd||Phase 2|
|Maastricht University Medical Center||Phase 4|
Generic filers with tentative approvals for FLUCONAZOLE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for fluconazole
|Drug Class||Azole Antifungal |
|Mechanism of Action||Cytochrome P450 2C19 Inhibitors |
Cytochrome P450 3A4 Inhibitors
Cytochrome P450 2C9 Inhibitors
Medical Subject Heading (MeSH) Categories for fluconazole
ATC Classes for fluconazole
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