Details for New Drug Application (NDA): 211661
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The generic ingredient in VORICONAZOLE is voriconazole. There are fourteen drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the voriconazole profile page.
Summary for 211661
Tradename: | VORICONAZOLE |
Applicant: | Slate Run Pharma |
Ingredient: | voriconazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 211661
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VORICONAZOLE | voriconazole | INJECTABLE;INTRAVENOUS | 211661 | ANDA | Slate Run Pharmaceuticals | 70436-029 | 70436-029-80 | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 BOX (70436-029-80) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 200MG/VIAL | ||||
Approval Date: | Nov 30, 2018 | TE: | AP | RLD: | No |
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