Details for New Drug Application (NDA): 210123
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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 210123
Tradename: | FLUOROURACIL |
Applicant: | Gland Pharma Ltd |
Ingredient: | fluorouracil |
Patents: | 0 |
Formulation / Manufacturing: | see details |
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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