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Details for New Drug Application (NDA): 065203

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NDA 065203 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, Glenmark Pharms Ltd, and Dr Reddys Labs Ltd, and is included in sixty-one 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. Thirteen suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.

Summary for NDA: 065203

Tradename:
NYSTATIN
Applicant:
Mayne Pharma Inc
Ingredient:
nystatin
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Pharmacology for NDA: 065203

Ingredient-typePolyenes

Suppliers and Packaging for NDA: 065203

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NYSTATIN
nystatin
POWDER;TOPICAL 065203 ANDA Rebel Distributors Corp 42254-303 42254-303-15 15 g in 1 BOTTLE, PLASTIC (42254-303-15)
NYSTATIN
nystatin
POWDER;TOPICAL 065203 ANDA Mayne Pharma Inc. 68308-152 68308-152-15 15 g in 1 BOTTLE, PLASTIC (68308-152-15)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;TOPICALStrength100,000 UNITS/GM
Approval Date:Jul 15, 2004TE:ATRLD:Yes


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