Details for New Drug Application (NDA): 016831
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NDA 016831 describes EFUDEX, which is a drug marketed by Bausch and is included in one NDA. It is available from one supplier. Additional details are available on the EFUDEX profile page.
The generic ingredient in EFUDEX is fluorouracil. There are fifteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.
The generic ingredient in EFUDEX is fluorouracil. There are fifteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.
Summary for 016831
| Tradename: | EFUDEX |
| Applicant: | Bausch |
| Ingredient: | fluorouracil |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 016831
Suppliers and Packaging for NDA: 016831
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EFUDEX | fluorouracil | CREAM;TOPICAL | 016831 | NDA AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 0378-4791 | 0378-4791-06 | 1 TUBE in 1 CARTON (0378-4791-06) / 40 g in 1 TUBE |
| EFUDEX | fluorouracil | SOLUTION;TOPICAL | 016831 | NDA AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 0378-4791 | 0378-4791-06 | 1 TUBE in 1 CARTON (0378-4791-06) / 40 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 2% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AT | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;TOPICAL | Strength | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 5% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
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