Details for New Drug Application (NDA): 075837
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NDA 075837 describes FLOXURIDINE, which is a drug marketed by Am Regent, Fresenius Kabi Usa, and Hikma, and is included in three NDAs. It is available from three suppliers. Additional details are available on the FLOXURIDINE profile page.
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.
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 |
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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