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Generated: November 19, 2018

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Details for New Drug Application (NDA): 018299

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NDA 018299 describes VIROPTIC, which is a drug marketed by Monarch Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the VIROPTIC profile page.

The generic ingredient in VIROPTIC is trifluridine. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the trifluridine profile page.
Summary for 018299
Tradename:VIROPTIC
Applicant:Monarch Pharms
Ingredient:trifluridine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018299
Ingredient-typeNucleoside Analog
Mechanism of ActionNucleic Acid Synthesis Inhibitors
Medical Subject Heading (MeSH) Categories for 018299
Suppliers and Packaging for NDA: 018299
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIROPTIC trifluridine SOLUTION/DROPS;OPHTHALMIC 018299 NDA Pfizer Laboratories Div Pfizer Inc 61570-037 61570-037-75 1 BOTTLE, DROPPER in 1 CARTON (61570-037-75) > 7.5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength1%
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:Yes

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