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Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065183

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NDA 065183 describes NYSTATIN, which is a drug marketed by Actavis Mid Atlantic, Crown Labs Inc, Fougera Pharms, G And W Labs Inc, Perrigo New York, Taro, Vintage, Paddock Llc, Gavis Pharms, Lyne, Mayne Pharma Inc, Nesher Pharms, Upsher-smith Labs, X Gen Pharms, Allied Pharma Inc, Alpharma Us Pharms, Fougera Pharms Inc, Hi Tech Pharma, Morton Grove, Pharm Assoc, Pharmaderm, Pharmafair, Taro Pharm, Teva, Vintage Pharms, Vistapharm, Wockhardt, Heritage Pharms Inc, Quantum Pharmics, Sandoz, Sun Pharm Industries, Usl Pharma, Watson Labs, Fougera, Odyssey Pharms, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Perrigo Uk Finco, Akorn, Riconpharma Llc, and Teligent Pharma Inc, and is included in seventy-one NDAs. It is available from forty-eight 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. Eighteen suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.

Summary for 065183

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Pharmacology for NDA: 065183

Ingredient-typePolyenes

Suppliers and Packaging for NDA: 065183

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NYSTATIN nystatin POWDER;TOPICAL 065183 ANDA Upsher-Smith Laboratories Inc. 0832-0465 0832-0465-15 1 BOTTLE, PLASTIC in 1 CARTON (0832-0465-15) > 15 g in 1 BOTTLE, PLASTIC
NYSTATIN nystatin POWDER;TOPICAL 065183 ANDA Upsher-Smith Laboratories Inc. 0832-0465 0832-0465-60 1 BOTTLE, PLASTIC in 1 CARTON (0832-0465-60) > 60 g in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;TOPICALStrength100,000 UNITS/GM
Approval Date:May 3, 2005TE:ATRLD:No


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