Details for New Drug Application (NDA): 016988
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NDA 016988 describes FLUOROPLEX, which is a drug marketed by Chartwell Rx and Elorac and is included in two NDAs. It is available from one supplier. Additional details are available on the FLUOROPLEX profile page.
The generic ingredient in FLUOROPLEX 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.
The generic ingredient in FLUOROPLEX 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 016988
| Tradename: | FLUOROPLEX |
| Applicant: | Chartwell Rx |
| Ingredient: | fluorouracil |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 016988
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 016988
Suppliers and Packaging for NDA: 016988
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUOROPLEX | fluorouracil | CREAM;TOPICAL | 016988 | NDA | Almirall, LLC | 16110-812 | 16110-812-30 | 1 TUBE in 1 CARTON (16110-812-30) / 30 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CREAM;TOPICAL | Strength | 1% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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