Details for New Drug Application (NDA): 075837
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The generic ingredient in FLOXURIDINE is floxuridine. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the floxuridine profile page.
Summary for 075837
Tradename: | FLOXURIDINE |
Applicant: | Fresenius Kabi Usa |
Ingredient: | floxuridine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 075837
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLOXURIDINE | floxuridine | INJECTABLE;INJECTION | 075837 | ANDA | Fresenius Kabi USA, LLC | 63323-145 | 63323-145-07 | 1 VIAL in 1 CARTON (63323-145-07) / 5 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 500MG/VIAL | ||||
Approval Date: | Feb 22, 2001 | TE: | AP | RLD: | No |
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