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Details for New Drug Application (NDA): 206799
NDA 206799 describes VORICONAZOLE, which is a drug marketed by Amneal Pharms, Mylan Pharms Inc, Novel Labs Inc, Alvogen Inc, Sandoz Inc, Xellia Pharms Aps, Ajanta Pharma Ltd, Akorn, Appco Pharma Llc, Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Prinston Inc, Teva Pharms, and Zydus Pharms Usa Inc, and is included in seventeen NDAs. It is available from twenty-six suppliers. Additional details are available on the VORICONAZOLE profile page.
The generic ingredient in VORICONAZOLE is voriconazole. There are fourteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the voriconazole profile page.
The generic ingredient in VORICONAZOLE is voriconazole. There are fourteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the voriconazole profile page.
Summary for 206799
| Tradename: | VORICONAZOLE |
| Applicant: | Novel Labs Inc |
| Ingredient: | voriconazole |
| Patents: | 0 |
| Therapeutic Class: | Antifungals |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 206799
| Ingredient-type | Azoles |
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C9 Inhibitors |
Medical Subject Heading (MeSH) Categories for 206799
Suppliers and Packaging for NDA: 206799
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VORICONAZOLE | voriconazole | FOR SUSPENSION;ORAL | 206799 | ANDA | Novel Laboratories, Inc. | 40032-038 | N | 40032-038-60 |
| VORICONAZOLE | voriconazole | FOR SUSPENSION;ORAL | 206799 | ANDA | Lupin Pharmaceuticals,Inc. | 43386-038 | N | 43386-038-60 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 200MG/5ML | ||||
| Approval Date: | May 31, 2016 | TE: | AB | RLD: | No | ||||
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