Details for New Drug Application (NDA): 203609
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NDA 203609 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, Kindos, Marchar, Novast Labs, Sagent Pharms Inc, Sandoz, Smith And Nephew, Spectrum Pharms, and Teva Pharms Usa, and is included in forty 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-one 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-one suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.
Summary for 203609
| Tradename: | FLUOROURACIL |
| Applicant: | Sagent Pharms Inc |
| Ingredient: | fluorouracil |
| Patents: | 0 |
Pharmacology for NDA: 203609
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 203609
Suppliers and Packaging for NDA: 203609
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 203609 | ANDA | Sagent Pharmaceuticals | 25021-215 | 25021-215-98 | 1 BOTTLE in 1 CARTON (25021-215-98) / 50 mL in 1 BOTTLE |
| FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 203609 | ANDA | Sagent Pharmaceuticals | 25021-215 | 25021-215-99 | 1 BOTTLE in 1 CARTON (25021-215-99) / 100 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2.5GM/50ML (50MG/ML) | ||||
| Approval Date: | Feb 17, 2016 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5GM/100ML (50MG/ML) | ||||
| Approval Date: | Feb 17, 2016 | TE: | AP | RLD: | No | ||||
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