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Details for New Drug Application (NDA): 202960

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NDA 202960 describes ATOVAQUONE, which is a drug marketed by Amneal Pharms, Glenmark Generics, and Mylan Pharms Inc, and is included in three 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 fourteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the atovaquone; proguanil hydrochloride profile page.

Summary for NDA: 202960

Amneal Pharms
Therapeutic Class:Antiparasitics

Pharmacology for NDA: 202960

Suppliers and Packaging for NDA: 202960

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUSPENSION;ORAL 202960 ANDA Amneal Pharmaceuticals of New York, LLC 65162-693 65162-693-88 1 BOTTLE in 1 CARTON (65162-693-88) > 210 mL in 1 BOTTLE

Summary for product number 001

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

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