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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 207730


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NDA 207730 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-two 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-two suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.
Summary for 207730
Pharmacology for NDA: 207730
Suppliers and Packaging for NDA: 207730
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NYSTATIN AND TRIAMCINOLONE ACETONIDE nystatin; triamcinolone acetonide CREAM;TOPICAL 207730 ANDA Crown Laboratories 0316-0223 0316-0223-15 1 TUBE in 1 CARTON (0316-0223-15) / 15 g in 1 TUBE
NYSTATIN AND TRIAMCINOLONE ACETONIDE nystatin; triamcinolone acetonide CREAM;TOPICAL 207730 ANDA Crown Laboratories 0316-0223 0316-0223-30 1 TUBE in 1 CARTON (0316-0223-30) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength100,000 UNITS/GM;0.1%
Approval Date:Dec 26, 2017TE:ATRLD:No

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