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Last Updated: September 25, 2020

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Details for New Drug Application (NDA): 205438

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NDA 205438 describes TRIFLURIDINE, which is a drug marketed by Hi Tech and Sandoz Inc and is included in two NDAs. It is available from two suppliers. Additional details are available on the TRIFLURIDINE profile page.

The generic ingredient in TRIFLURIDINE is trifluridine. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the trifluridine profile page.
Summary for 205438
Applicant:Hi Tech
Formulation / Manufacturing:see details
Pharmacology for NDA: 205438
Medical Subject Heading (MeSH) Categories for 205438
Suppliers and Packaging for NDA: 205438
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRIFLURIDINE trifluridine SOLUTION/DROPS;OPHTHALMIC 205438 ANDA Hi-Tech Pharmacal Co., Inc. 50383-955 50383-955-07 1 BOTTLE, DROPPER in 1 CARTON (50383-955-07) > 7.5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength1%
Approval Date:Jul 28, 2017TE:ATRLD:No

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