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Federal Trade Commission

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078743

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NDA 078743 describes MALATHION, which is a drug marketed by Mylan Pharms Inc and Suven Life and is included in two NDAs. It is available from three suppliers. Additional details are available on the MALATHION profile page.

The generic ingredient in MALATHION is malathion. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the malathion profile page.
Summary for 078743
Applicant:Mylan Pharms Inc
Therapeutic Class:Antiparasitics
Formulation / Manufacturing:see details
Pharmacology for NDA: 078743
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 078743
Suppliers and Packaging for NDA: 078743
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MALATHION malathion LOTION;TOPICAL 078743 ANDA Karalex Pharma, LLC, Woodcliff Lake, NJ 07677 42043-150 N 42043-150-23

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:LOTION;TOPICALStrength0.5%
Approval Date:Mar 6, 2009TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
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