Details for New Drug Application (NDA): 210124
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NDA 210124 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 210124
| Tradename: | FLUOROURACIL |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | fluorouracil |
| Patents: | 0 |
Pharmacology for NDA: 210124
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 210124
Suppliers and Packaging for NDA: 210124
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 210124 | ANDA | BluePoint Laboratories | 68001-525 | 68001-525-27 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68001-525-27) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 210124 | ANDA | BluePoint Laboratories | 68001-525 | 68001-525-32 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68001-525-32) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2.5GM/50ML (50MG/ML) | ||||
| Approval Date: | Dec 26, 2017 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5GM/100ML (50MG/ML) | ||||
| Approval Date: | Dec 26, 2017 | TE: | AP | RLD: | No | ||||
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