Details for New Drug Application (NDA): 209219
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The generic ingredient in FLUOROURACIL is fluorouracil. There are fifteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.
Summary for 209219
Tradename: | FLUOROURACIL |
Applicant: | Novast Labs |
Ingredient: | fluorouracil |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 209219
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 500MG/10ML (50MG/ML) | ||||
Approval Date: | Dec 12, 2019 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 1GM/20ML (50MG/ML) | ||||
Approval Date: | Dec 12, 2019 | TE: | RLD: | No |
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