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, Ingenus Pharms Llc, Kindos, Marchar, Sagent Pharms Inc, Sandoz, Smith And Nephew, Spectrum Pharms, and Teva Pharms Usa, and is included in forty NDAs. It is available from eighteen suppliers. Additional details are available on the FLUOROURACIL profile page.
The generic ingredient in FLUOROURACIL is fluorouracil. There is one drug master file entry for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.
The generic ingredient in FLUOROURACIL is fluorouracil. There is one drug master file entry for this compound. Twenty-three 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 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-972 | 23155-972-41 | 10 VIAL, SINGLE-DOSE in 1 CARTON (23155-972-41) / 10 mL in 1 VIAL, SINGLE-DOSE (23155-972-31) |
| FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 210123 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-973 | 23155-973-41 | 10 VIAL, SINGLE-DOSE in 1 CARTON (23155-973-41) / 20 mL in 1 VIAL, SINGLE-DOSE (23155-973-31) |
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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