Details for New Drug Application (NDA): 218533
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NDA 218533 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, 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-seven NDAs. It is available from thirty 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-one 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-one suppliers are listed for this compound. Additional details are available on the voriconazole profile page.
Summary for 218533
| Tradename: | VORICONAZOLE |
| Applicant: | Aspiro |
| Ingredient: | voriconazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 218533
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VORICONAZOLE | voriconazole | POWDER;INTRAVENOUS | 218533 | ANDA | Camber Pharmaceuticals, Inc. | 31722-224 | 31722-224-31 | 1 VIAL, SINGLE-DOSE in 1 CARTON (31722-224-31) / 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: | Apr 3, 2024 | TE: | AP | RLD: | No | ||||
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