Details for New Drug Application (NDA): 215612
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The generic ingredient in FLUOROURACIL is fluorouracil. There are fifteen drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.
Summary for 215612
Tradename: | FLUOROURACIL |
Applicant: | Encube |
Ingredient: | fluorouracil |
Patents: | 0 |
Pharmacology for NDA: 215612
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 215612
Suppliers and Packaging for NDA: 215612
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUOROURACIL | fluorouracil | SOLUTION;TOPICAL | 215612 | ANDA | Encube Ethicals Private Limited | 21922-041 | 21922-041-12 | 1 BOTTLE in 1 CARTON (21922-041-12) / 10 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 5% | ||||
Approval Date: | Nov 2, 2023 | TE: | AT | RLD: | No |
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