Details for New Drug Application (NDA): 208300
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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 208300
Tradename: | NYSTATIN AND TRIAMCINOLONE ACETONIDE |
Applicant: | Glenmark Pharms Ltd |
Ingredient: | nystatin; triamcinolone acetonide |
Patents: | 0 |
Pharmacology for NDA: 208300
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 208300
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NYSTATIN AND TRIAMCINOLONE ACETONIDE | nystatin; triamcinolone acetonide | OINTMENT;TOPICAL | 208300 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-799 | 68462-799-17 | 1 TUBE in 1 CARTON (68462-799-17) / 15 g in 1 TUBE |
NYSTATIN AND TRIAMCINOLONE ACETONIDE | nystatin; triamcinolone acetonide | OINTMENT;TOPICAL | 208300 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-799 | 68462-799-35 | 1 TUBE in 1 CARTON (68462-799-35) / 30 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 100,000 UNITS/GM;0.1% | ||||
Approval Date: | Jun 23, 2016 | TE: | AT | RLD: | No |
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