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Last Updated: December 5, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 064118

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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. Forty-two suppliers are listed for this compound. Additional details are available on the nystatin profile page.
Summary for 064118
Tradename:NYSTOP
Applicant:Paddock Llc
Ingredient:nystatin
Patents:0
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

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