Details for New Drug Application (NDA): 214845
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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 214845
Tradename: | FLUOROURACIL |
Applicant: | Accord Hlthcare |
Ingredient: | fluorouracil |
Patents: | 0 |
Pharmacology for NDA: 214845
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 214845
Suppliers and Packaging for NDA: 214845
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUOROURACIL | fluorouracil | CREAM;TOPICAL | 214845 | ANDA | Accord Healthcare Inc. | 16729-542 | 16729-542-35 | 1 TUBE in 1 CARTON (16729-542-35) / 40 g in 1 TUBE |
FLUOROURACIL | fluorouracil | CREAM;TOPICAL | 214845 | ANDA | NuCare Pharmaceuticals,Inc. | 68071-2961 | 68071-2961-4 | 1 TUBE in 1 CARTON (68071-2961-4) / 40 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 5% | ||||
Approval Date: | Oct 7, 2021 | TE: | AB | RLD: | No |
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