Details for New Drug Application (NDA): 220043
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NDA 220043 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 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 220043
| Tradename: | VORICONAZOLE |
| Applicant: | Hainan Poly Pharm |
| Ingredient: | voriconazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 220043
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VORICONAZOLE | voriconazole | SOLUTION;INTRAVENOUS | 220043 | ANDA | Hainan Poly Pharm. Co., Ltd. | 14335-730 | 14335-730-10 | 1 VIAL, SINGLE-USE in 1 CARTON (14335-730-10) / 20 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 200MG/20ML (10MG/ML) | ||||
| Approval Date: | Nov 14, 2025 | TE: | RLD: | No | |||||
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