Details for New Drug Application (NDA): 208479
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NDA 208479 describes NYSTATIN AND TRIAMCINOLONE ACETONIDE, which is a drug marketed by Alembic, Alpharma Us Pharms, Amneal, Crown Labs Inc, Dr Reddys, Fougera Pharms Inc, Glenmark Pharms Ltd, Lupin Ltd, Macleods Pharms Ltd, Padagis Israel, Perrigo New York, Pharmafair, Taro, Torrent, Chartwell Rx, Epic Pharma Llc, Pai Holdings Pharm, Rising, Strides Pharma, and Zydus Lifesciences, and is included in thirty-one NDAs. It is available from twenty-one suppliers. Additional details are available on the NYSTATIN AND TRIAMCINOLONE ACETONIDE profile page.
The generic ingredient in NYSTATIN AND TRIAMCINOLONE ACETONIDE is nystatin; triamcinolone acetonide. There are eight drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.
The generic ingredient in NYSTATIN AND TRIAMCINOLONE ACETONIDE is nystatin; triamcinolone acetonide. There are eight drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.
Summary for 208479
| Tradename: | NYSTATIN AND TRIAMCINOLONE ACETONIDE |
| Applicant: | Padagis Israel |
| Ingredient: | nystatin; triamcinolone acetonide |
| Patents: | 0 |
Pharmacology for NDA: 208479
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 208479
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NYSTATIN AND TRIAMCINOLONE ACETONIDE | nystatin; triamcinolone acetonide | CREAM;TOPICAL | 208479 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-880 | 45802-880-14 | 1 TUBE in 1 CARTON (45802-880-14) / 15 g in 1 TUBE |
| NYSTATIN AND TRIAMCINOLONE ACETONIDE | nystatin; triamcinolone acetonide | CREAM;TOPICAL | 208479 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-880 | 45802-880-94 | 1 TUBE in 1 CARTON (45802-880-94) / 30 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: | Aug 14, 2017 | TE: | AT | RLD: | No | ||||
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