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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

Tradename:
NYSTOP
Applicant:
Paddock Llc
Ingredient:
nystatin
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Pharmacology for NDA: 064118

Ingredient-typePolyenes

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)

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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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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