Details for New Drug Application (NDA): 208205
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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 208205
Tradename: | NYSTATIN AND TRIAMCINOLONE ACETONIDE |
Applicant: | Lupin Ltd |
Ingredient: | nystatin; triamcinolone acetonide |
Patents: | 0 |
Pharmacology for NDA: 208205
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 208205
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NYSTATIN AND TRIAMCINOLONE ACETONIDE | nystatin; triamcinolone acetonide | CREAM;TOPICAL | 208205 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-545 | 68180-545-02 | 1 TUBE in 1 CARTON (68180-545-02) / 30 g in 1 TUBE |
NYSTATIN AND TRIAMCINOLONE ACETONIDE | nystatin; triamcinolone acetonide | CREAM;TOPICAL | 208205 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-545 | 68180-545-03 | 1 TUBE in 1 CARTON (68180-545-03) / 60 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 100,000 UNITS/GM;0.1% | ||||
Approval Date: | May 31, 2018 | TE: | AT | RLD: | No |
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