Details for New Drug Application (NDA): 062606
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NDA 062606 describes MYCOLOG-II, which is a drug marketed by Delcor Asset Corp and Mylan and is included in three NDAs. Additional details are available on the MYCOLOG-II profile page.
The generic ingredient in MYCOLOG-II is nystatin; triamcinolone acetonide. There are eight drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.
The generic ingredient in MYCOLOG-II is nystatin; triamcinolone acetonide. There are eight drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.
Summary for 062606
| Tradename: | MYCOLOG-II |
| Applicant: | Mylan |
| Ingredient: | nystatin; triamcinolone acetonide |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CREAM;TOPICAL | Strength | 100,000 UNITS/GM;0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | ||||
| Approval Date: | May 15, 1985 | TE: | RLD: | No | |||||
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