Details for New Drug Application (NDA): 207730
NDA 207730 describes NYSTATIN AND TRIAMCINOLONE ACETONIDE, which is a drug marketed by Alembic, Alpharma Us Pharms, Amneal, Chartwell Rx, Crown Labs Inc, Fougera Pharms Inc, Glenmark Pharms Ltd, Lupin, Macleods Pharms, Padagis Israel, Perrigo New York, Pharmafair, Sun Pharma Canada, Torrent, Dr Reddys, Epic Pharma Llc, Pai Holdings Pharm, Rising, Strides Pharma, and Zydus Lifesciences, and is included in thirty-one NDAs. It is available from seventeen 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 is one drug master file entry for this compound. Seventeen 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 is one drug master file entry for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.
Summary for 207730
| Tradename: | NYSTATIN AND TRIAMCINOLONE ACETONIDE |
| Applicant: | Crown Labs Inc |
| Ingredient: | nystatin; triamcinolone acetonide |
| Patents: | 0 |
Pharmacology for NDA: 207730
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 100,000 UNITS/GM;0.1% | ||||
| Approval Date: | Dec 26, 2017 | TE: | AT | RLD: | No | ||||
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