Details for New Drug Application (NDA): 216805
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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 216805
Tradename: | VORICONAZOLE |
Applicant: | Hainan Poly |
Ingredient: | voriconazole |
Patents: | 0 |
Suppliers and Packaging for NDA: 216805
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VORICONAZOLE | voriconazole | FOR SUSPENSION;ORAL | 216805 | ANDA | Hainan Poly Pharm. Co., Ltd | 14335-220 | 14335-220-01 | 1 BOTTLE in 1 CARTON (14335-220-01) / 75 mL in 1 BOTTLE |
VORICONAZOLE | voriconazole | FOR SUSPENSION;ORAL | 216805 | ANDA | Slate Run Pharmaceuticals, LLC | 70436-230 | 70436-230-39 | 1 BOTTLE in 1 CARTON (70436-230-39) / 75 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 200MG/5ML | ||||
Approval Date: | Jan 2, 2024 | TE: | AB | RLD: | No |
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