Details for New Drug Application (NDA): 208983
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The generic ingredient in VORICONAZOLE is voriconazole. There are fourteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the voriconazole profile page.
Summary for 208983
Tradename: | VORICONAZOLE |
Applicant: | Zydus Pharms |
Ingredient: | voriconazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 208983
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VORICONAZOLE | voriconazole | INJECTABLE;INTRAVENOUS | 208983 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1247 | 70710-1247-1 | 1 VIAL, SINGLE-DOSE in 1 CARTON (70710-1247-1) / 20 mL in 1 VIAL, SINGLE-DOSE |
VORICONAZOLE | voriconazole | INJECTABLE;INTRAVENOUS | 208983 | ANDA | Zydus Lifesciences Limited | 70771-1413 | 70771-1413-1 | 1 VIAL, SINGLE-DOSE in 1 CARTON (70771-1413-1) / 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: | Jul 16, 2018 | TE: | AP | RLD: | No |
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