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Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202960

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NDA 202960 describes ATOVAQUONE, which is a drug marketed by Amneal Pharms, Apotex Inc, Paddock Llc, Glenmark Generics, and Mylan Pharms Inc, and is included in five NDAs. It is available from one supplier. Additional details are available on the ATOVAQUONE profile page.

The generic ingredient in ATOVAQUONE is atovaquone; proguanil hydrochloride. There are sixteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the atovaquone; proguanil hydrochloride profile page.
Summary for 202960
Applicant:Amneal Pharms
Therapeutic Class:Antiparasitics
Formulation / Manufacturing:see details
Pharmacology for NDA: 202960
Medical Subject Heading (MeSH) Categories for 202960
Suppliers and Packaging for NDA: 202960
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATOVAQUONE atovaquone SUSPENSION;ORAL 202960 ANDA Amneal Pharmaceuticals LLC 65162-693 N 65162-693-88

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength750MG/5ML
Approval Date:Mar 18, 2014TE:ABRLD:No

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