Details for New Drug Application (NDA): 217295
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NDA 217295 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. Nineteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.
Summary for 217295
| Tradename: | FLUOROURACIL |
| Applicant: | Alembic |
| Ingredient: | fluorouracil |
| Patents: | 0 |
Pharmacology for NDA: 217295
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 217295
Suppliers and Packaging for NDA: 217295
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 217295 | ANDA | Alembic Pharmaceuticals Limited | 46708-751 | 46708-751-50 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (46708-751-50) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 217295 | ANDA | Alembic Pharmaceuticals Inc. | 62332-751 | 62332-751-50 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (62332-751-50) / 50 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: | Mar 3, 2023 | TE: | AP | RLD: | No | ||||
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