Details for New Drug Application (NDA): 061966
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The generic ingredient in NYSTATIN 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.
Suppliers and Packaging for NDA: 061966
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NYSTATIN | nystatin | CREAM;TOPICAL | 061966 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0678 | 0713-0678-15 | 1 TUBE in 1 CARTON (0713-0678-15) / 15 g in 1 TUBE |
NYSTATIN | nystatin | CREAM;TOPICAL | 061966 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0678 | 0713-0678-31 | 1 TUBE in 1 CARTON (0713-0678-31) / 30 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 100,000 UNITS/GM | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AT | RLD: | No |
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