➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Harvard Business School
Express Scripts
Boehringer Ingelheim
Johnson and Johnson

Last Updated: July 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 064118

Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

NDA 064118 describes NYSTOP, which is a drug marketed by Paddock Llc and is included in one NDA. It is available from one supplier. Additional details are available on the NYSTOP profile page.

The generic ingredient in NYSTOP is nystatin. There are eight drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the nystatin profile page.
Summary for 064118
Applicant:Paddock Llc
Formulation / Manufacturing:see details
Pharmacology for NDA: 064118
Medical Subject Heading (MeSH) Categories for 064118
Suppliers and Packaging for NDA: 064118
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NYSTOP nystatin POWDER;TOPICAL 064118 ANDA Paddock Laboratories, LLC 0574-2008 0574-2008-02 60 g in 1 BOTTLE, PLASTIC (0574-2008-02)
NYSTOP nystatin POWDER;TOPICAL 064118 ANDA Paddock Laboratories, LLC 0574-2008 0574-2008-15 15 g in 1 BOTTLE, PLASTIC (0574-2008-15)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;TOPICALStrength100,000 UNITS/GM
Approval Date:Aug 16, 1996TE:ATRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson

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 verification 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.