Details for New Drug Application (NDA): 040798
NDA 040798 describes FLUOROURACIL, which is a drug marketed by Accord Hlthcare, Dr Reddys Labs Sa, Encube, Extrovis, Taro, Abic, Abraxis Pharm, Alembic, Bedford, Ebewe Pharma, Eugia Pharma Speclts, Fresenius Kabi Usa, Gland, Ingenus Pharms Llc, Kindos, Marchar, Sagent Pharms Inc, Sandoz, Smith And Nephew, Spectrum Pharms, and Teva Pharms Usa, and is included in forty NDAs. It is available from eighteen suppliers. Additional details are available on the FLUOROURACIL profile page.
The generic ingredient in FLUOROURACIL is fluorouracil. There is one drug master file entry for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.
The generic ingredient in FLUOROURACIL is fluorouracil. There is one drug master file entry for this compound. Twenty-two 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 |
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: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 2.5GM/50ML (50MG/ML) | ||||
| Approval Date: | Apr 26, 2007 | TE: | RLD: | No | |||||
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