Details for New Drug Application (NDA): 206654
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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 206654
Tradename: | VORICONAZOLE |
Applicant: | Prinston Inc |
Ingredient: | voriconazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 206654
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VORICONAZOLE | voriconazole | TABLET;ORAL | 206654 | ANDA | Solco Healthcare U.S., LLC | 43547-377 | 43547-377-03 | 30 TABLET, COATED in 1 BOTTLE (43547-377-03) |
VORICONAZOLE | voriconazole | TABLET;ORAL | 206654 | ANDA | Solco Healthcare U.S., LLC | 43547-377 | 43547-377-50 | 500 TABLET, COATED in 1 BOTTLE (43547-377-50) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Aug 8, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Aug 8, 2016 | TE: | AB | RLD: | No |
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