Details for New Drug Application (NDA): 217676
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NDA 217676 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 217676
| Tradename: | FLUOROURACIL |
| Applicant: | Alembic |
| Ingredient: | fluorouracil |
| Patents: | 0 |
Pharmacology for NDA: 217676
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 217676
Suppliers and Packaging for NDA: 217676
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 217676 | ANDA | Alembic Pharmaceuticals Limited | 46708-779 | 46708-779-31 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (46708-779-31) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 217676 | ANDA | Alembic Pharmaceuticals Inc. | 62332-779 | 62332-779-31 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (62332-779-31) / 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: | Oct 18, 2023 | TE: | AP | RLD: | No | ||||
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