Details for New Drug Application (NDA): 077524
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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 077524
Tradename: | FLUOROURACIL |
Applicant: | Dr Reddys Labs Sa |
Ingredient: | fluorouracil |
Patents: | 0 |
Pharmacology for NDA: 077524
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 077524
Suppliers and Packaging for NDA: 077524
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUOROURACIL | fluorouracil | CREAM;TOPICAL | 077524 | ANDA | Mayne Pharma Inc. | 51862-362 | 51862-362-40 | 1 TUBE in 1 CARTON (51862-362-40) / 40 g in 1 TUBE |
FLUOROURACIL | fluorouracil | CREAM;TOPICAL | 077524 | ANDA | Dr. Reddy's Labratories Inc. | 75907-095 | 75907-095-40 | 1 TUBE in 1 CARTON (75907-095-40) / 40 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 5% | ||||
Approval Date: | Apr 11, 2008 | TE: | AB | RLD: | No |
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