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Details for New Drug Application (NDA): 062225

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NDA 062225 describes NYSTATIN, which is a drug marketed by Watson Labs, Teva, Mayne Pharma Inc, Quantum Pharmics, Wockhardt, Paddock Llc, Vintage, Odyssey Pharms, Fougera, Pharmaderm, Nesher Pharms, Pharm Assoc, Taro, Vistapharm, Fougera Pharms, Usl Pharma, Perrigo New York, Roxane, Morton Grove, Gavis Pharms, Sun Pharm Inds, Actavis Mid Atlantic, Pharmafair, Hi Tech Pharma, Vintage Pharms, G And W Labs Inc, Sandoz, Alpharma Us Pharms, Heritage Pharms Inc, X Gen Pharms, Upsher Smith, and Glenmark Pharms Ltd, and is included in fifty-nine NDAs. It is available from forty-seven suppliers. Additional details are available on the NYSTATIN profile page.

The generic ingredient in NYSTATIN is nystatin; triamcinolone acetonide. There are eight drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.

Summary for NDA: 062225

Perrigo New York
Therapeutic Class:Antifungals

Pharmacology for NDA: 062225


Suppliers and Packaging for NDA: 062225

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CREAM;TOPICAL 062225 ANDA Perrigo New York Inc 45802-059 45802-059-11 1 TUBE in 1 CARTON (45802-059-11) > 30 g in 1 TUBE
CREAM;TOPICAL 062225 ANDA Perrigo New York Inc 45802-059 45802-059-35 1 TUBE in 1 CARTON (45802-059-35) > 15 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength100,000 UNITS/GM
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:No

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