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Generated: April 24, 2017

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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 two suppliers. 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-eight suppliers are listed for this compound. Additional details are available on the nystatin profile page.

Summary for NDA: 064118

Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Pharmacology for NDA: 064118


Suppliers and Packaging for NDA: 064118

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
POWDER;TOPICAL 064118 ANDA Paddock Laboratories, LLC 0574-2008 0574-2008-02 60 g in 1 BOTTLE, PLASTIC (0574-2008-02)
POWDER;TOPICAL 064118 ANDA Paddock Laboratories, LLC 0574-2008 0574-2008-15 15 g in 1 BOTTLE, PLASTIC (0574-2008-15)

Summary 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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