Details for New Drug Application (NDA): 040798
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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 040798
Tradename: | FLUOROURACIL |
Applicant: | Accord Hlthcare |
Ingredient: | fluorouracil |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 040798
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 040798
Suppliers and Packaging for NDA: 040798
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 040798 | ANDA | Accord Healthcare, Inc. | 16729-276 | 16729-276-11 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (16729-276-11) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE |
FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 040798 | ANDA | Accord Healthcare, Inc. | 16729-276 | 16729-276-38 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (16729-276-38) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5GM/100ML (50MG/ML) | ||||
Approval Date: | Apr 26, 2007 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2.5GM/50ML (50MG/ML) | ||||
Approval Date: | Apr 26, 2007 | TE: | AP | RLD: | No |
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