Details for New Drug Application (NDA): 075387
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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 075387
Tradename: | FLOXURIDINE |
Applicant: | Hikma |
Ingredient: | floxuridine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 075387
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLOXURIDINE | floxuridine | INJECTABLE;INJECTION | 075387 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9270 | 0143-9270-01 | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9270-01) / 5 mL in 1 VIAL |
FLOXURIDINE | floxuridine | INJECTABLE;INJECTION | 075387 | ANDA | Cerona Therapeutics, Inc. | 81643-9270 | 81643-9270-1 | 1 VIAL in 1 BOX, UNIT-DOSE (81643-9270-1) / 5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 500MG/VIAL | ||||
Approval Date: | Apr 16, 2000 | TE: | AP | RLD: | No |
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