Details for New Drug Application (NDA): 040279
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NDA 040279 describes FLUOROURACIL, which is a drug marketed by Accord Hlthcare, Dr Reddys Labs Sa, Rising, Taro, Abic, Abraxis Pharm, Alembic, Bedford, Ebewe Pharma, Eugia Pharma Speclts, Fresenius Kabi Usa, Gland Pharma Ltd, Kindos, Marchar, Novast Labs, Sagent Pharms Inc, Sandoz, Smith And Nephew, Spectrum Pharms, Teva Pharms Usa, and Encube, and is included in thirty-eight NDAs. It is available from seventeen suppliers. Additional details are available on the FLUOROURACIL profile page.
The generic ingredient in FLUOROURACIL is fluorouracil. There are fifteen drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.
The generic ingredient in FLUOROURACIL is fluorouracil. There are fifteen drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.
Summary for 040279
| Tradename: | FLUOROURACIL |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | fluorouracil |
| Patents: | 0 |
Pharmacology for NDA: 040279
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 040279
Suppliers and Packaging for NDA: 040279
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 040279 | ANDA | Fresenius Kabi USA, LLC | 63323-117 | 63323-117-10 | 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-117-10) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-117-00) |
| FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 040279 | ANDA | Fresenius Kabi USA, LLC | 63323-117 | 63323-117-20 | 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-117-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-117-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1GM/20ML (50MG/ML) | ||||
| Approval Date: | Sep 30, 1998 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 500MG/10ML (50MG/ML) | ||||
| Approval Date: | Sep 30, 1998 | TE: | AP | RLD: | No | ||||
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