Details for New Drug Application (NDA): 208562
✉ Email this page to a colleague
NDA 208562 describes VORICONAZOLE, which is a drug marketed by Amneal Pharms, Hetero Labs Ltd V, Novel Labs Inc, Rising, Zhejiang Poly Pharm, Almaject, Aspiro, Eugia Pharma, Gland, Hikma, Meitheal, Pharmobedient, Sandoz Inc, Slate Run Pharma, UBI, Zydus Pharms, Hainan Poly Pharm, 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-eight NDAs. It is available from thirty-one 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-two 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-two suppliers are listed for this compound. Additional details are available on the voriconazole profile page.
Summary for 208562
| Tradename: | VORICONAZOLE |
| Applicant: | Hikma |
| 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 | POWDER;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: | POWDER;INTRAVENOUS | Strength | 200MG/VIAL | ||||
| Approval Date: | Mar 9, 2017 | TE: | AP | RLD: | No | ||||
Complete Access Available with Subscription
