Details for New Drug Application (NDA): 212162
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NDA 212162 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, Hainan Poly, Hikma, Meitheal, Pharmobedient, Sandoz Inc, UBI, Zhejiang Novus, 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-nine NDAs. It is available from thirty-two suppliers. Additional details are available on the VORICONAZOLE profile page.
The generic ingredient in VORICONAZOLE is voriconazole. There is one drug master file entry for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the voriconazole profile page.
The generic ingredient in VORICONAZOLE is voriconazole. There is one drug master file entry for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the voriconazole profile page.
Summary for 212162
| Tradename: | VORICONAZOLE |
| Applicant: | Eugia Pharma |
| Ingredient: | voriconazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 212162
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VORICONAZOLE | voriconazole | POWDER;INTRAVENOUS | 212162 | ANDA | Eugia US LLC | 55150-321 | 55150-321-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-321-01) / 20 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER;INTRAVENOUS | Strength | 200MG/VIAL | ||||
| Approval Date: | Feb 2, 2023 | TE: | RLD: | No | |||||
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