Details for New Drug Application (NDA): 210123
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NDA 210123 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-two 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-two suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.
Summary for 210123
| Tradename: | FLUOROURACIL |
| Applicant: | Gland |
| Ingredient: | fluorouracil |
| Patents: | 0 |
Pharmacology for NDA: 210123
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 210123
Suppliers and Packaging for NDA: 210123
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 210123 | ANDA | BluePoint Laboratories | 68001-524 | 68001-524-30 | 10 VIAL in 1 CARTON (68001-524-30) / 10 mL in 1 VIAL (68001-524-28) |
| FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 210123 | ANDA | BluePoint Laboratories | 68001-524 | 68001-524-31 | 10 VIAL in 1 CARTON (68001-524-31) / 20 mL in 1 VIAL (68001-524-29) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 500MG/10ML (50MG/ML) | ||||
| Approval Date: | Oct 27, 2017 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1GM/20ML (50MG/ML) | ||||
| Approval Date: | Oct 27, 2017 | TE: | AP | RLD: | No | ||||
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