Details for New Drug Application (NDA): 208562
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NDA 208562 describes VORICONAZOLE, which is a drug marketed by Amneal Pharms, Hainan Poly, Novel Labs Inc, Rising, Almaject, Aspiro, Eugia Pharma, Gland Pharma Ltd, Meitheal, Norvium Bioscience, Sandoz Inc, Slate Run Pharma, UBI, Xellia Pharms Aps, Zydus Pharms, Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Cadila, Chartwell Rx, Epic Pharma Llc, Glenmark Pharms Ltd, Mylan Pharms Inc, Prinston Inc, and Teva Pharms, and is included in twenty-six NDAs. It is available from thirty-four 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. Thirty-six 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. Thirty-six suppliers are listed for this compound. Additional details are available on the voriconazole profile page.
Summary for 208562
| Tradename: | VORICONAZOLE |
| Applicant: | Xellia Pharms Aps |
| Ingredient: | voriconazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 208562
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VORICONAZOLE | voriconazole | INJECTABLE;INTRAVENOUS | 208562 | NDA | XGen Pharmaceuticals DJB, Inc. | 39822-1077 | 39822-1077-1 | 1 VIAL, SINGLE-DOSE in 1 CARTON (39822-1077-1) / 20 mL in 1 VIAL, SINGLE-DOSE |
| VORICONAZOLE | voriconazole | INJECTABLE;INTRAVENOUS | 208562 | NDA | Xellia Pharmaceuticals USA LLC | 70594-067 | 70594-067-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (70594-067-01) / 20 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 200MG/VIAL | ||||
| Approval Date: | Mar 9, 2017 | TE: | AP | RLD: | No | ||||
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