Details for New Drug Application (NDA): 202669
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The generic ingredient in FLUOROURACIL is fluorouracil. There are fifteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.
Summary for 202669
Tradename: | FLUOROURACIL |
Applicant: | Eugia Pharma Speclts |
Ingredient: | fluorouracil |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202669
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 202669
Suppliers and Packaging for NDA: 202669
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 202669 | ANDA | Eugia US LLC | 55150-498 | 55150-498-01 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-498-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 202669 | ANDA | Eugia US LLC | 55150-499 | 55150-499-01 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-499-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2.5GM/50ML (50MG/ML) | ||||
Approval Date: | Jul 17, 2012 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5GM/100ML (50MG/ML) | ||||
Approval Date: | Jul 17, 2012 | TE: | AP | RLD: | No |
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