Deeper Knowledge, Faster

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Drug patents in 130+ countries
➤ Start Trial

or, See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
US Department of Justice
Farmers Insurance
Federal Trade Commission

Generated: March 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 062517

« Back to Dashboard

NDA 062517 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 Bio Ag, Heritage Pharms Inc, Quantum Pharmics, Sandoz, Sun Pharm Industries, Usl Pharma, Watson Labs, Fougera, Odyssey Pharms, Amneal Pharms Llc, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Perrigo Uk Finco, Akorn, Riconpharma Llc, Strides Pharma, and Teligent Pharma Inc, and is included in seventy-five NDAs. It is available from forty-five 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 062517
Applicant:Fougera Pharms Inc
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Pharmacology for NDA: 062517
Medical Subject Heading (MeSH) Categories for 062517
Suppliers and Packaging for NDA: 062517
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NYSTATIN nystatin SUSPENSION;ORAL 062517 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0037 N 0168-0037-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength100,000 UNITS/ML
Approval Date:Jun 7, 1984TE:AARLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Chinese Patent Office
Boehringer Ingelheim

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.