Details for New Drug Application (NDA): 062599
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The generic ingredient in NYSTATIN AND TRIAMCINOLONE ACETONIDE 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 062599
Tradename: | NYSTATIN AND TRIAMCINOLONE ACETONIDE |
Applicant: | Fougera Pharms Inc |
Ingredient: | nystatin; triamcinolone acetonide |
Patents: | 0 |
Pharmacology for NDA: 062599
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 062599
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NYSTATIN AND TRIAMCINOLONE ACETONIDE | nystatin; triamcinolone acetonide | CREAM;TOPICAL | 062599 | ANDA | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0081 | 0168-0081-15 | 15 g in 1 TUBE (0168-0081-15) |
NYSTATIN AND TRIAMCINOLONE ACETONIDE | nystatin; triamcinolone acetonide | CREAM;TOPICAL | 062599 | ANDA | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0081 | 0168-0081-30 | 30 g in 1 TUBE (0168-0081-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 100,000 UNITS/GM;0.1% | ||||
Approval Date: | Oct 8, 1985 | TE: | AT | RLD: | No |
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