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Serving 500+ biopharmaceutical companies globally:

Merck
Dow
Mallinckrodt
Cerilliant
AstraZeneca
Queensland Health
Colorcon
Farmers Insurance
Medtronic
Argus Health

Generated: June 27, 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 Watson Labs, Teva, Mayne Pharma Inc, Quantum Pharmics, Wockhardt, Paddock Llc, Vintage, Odyssey Pharms, Fougera Pharms Inc, Pharmaderm, Nesher Pharms, Pharm Assoc, Taro, Vistapharm, Fougera Pharms, Usl Pharma, Perrigo New York, Roxane, Morton Grove, Gavis Pharms, Lyne, Sun Pharm Inds, Actavis Mid Atlantic, Pharmafair, Hi Tech Pharma, Vintage Pharms, G And W Labs Inc, Fougera, Sandoz, Alpharma Us Pharms, Heritage Pharms Inc, X Gen Pharms, Taro Pharm, Upsher Smith, Glenmark Pharms Ltd, Dr Reddys Labs Ltd, Perrigo Uk Finco, Riconpharma Llc, and Teligent Pharma Inc, and is included in sixty-seven NDAs. It is available from forty-six 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. Fourteen suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.

Summary for NDA: 065183

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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 0832-0465-30 1 BOTTLE, PLASTIC in 1 CARTON (0832-0465-30) > 30 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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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Fuji
Federal Trade Commission
Covington
Julphar
Citi
Medtronic
Cerilliant
Deloitte
McKesson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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