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Generated: May 30, 2017

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Details for New Drug Application (NDA): 091211

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NDA 091211 describes ATOVAQUONE AND PROGUANIL HYDROCHLORIDE, which is a drug marketed by Glenmark Generics and Mylan Pharms Inc and is included in two NDAs. It is available from twelve suppliers. Additional details are available on the ATOVAQUONE AND PROGUANIL HYDROCHLORIDE profile page.

The generic ingredient in ATOVAQUONE AND PROGUANIL HYDROCHLORIDE is atovaquone; proguanil hydrochloride. There are fifteen 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: 091211

Therapeutic Class:Antiparasitics
Formulation / Manufacturing:see details

Pharmacology for NDA: 091211

Suppliers and Packaging for NDA: 091211

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
atovaquone; proguanil hydrochloride
TABLET;ORAL 091211 ANDA Blenheim Pharmacal, Inc. 10544-909 10544-909-05 5 TABLET, FILM COATED in 1 BOTTLE (10544-909-05)
atovaquone; proguanil hydrochloride
TABLET;ORAL 091211 ANDA Blenheim Pharmacal, Inc. 10544-909 10544-909-10 10 TABLET, FILM COATED in 1 BOTTLE (10544-909-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG;100MG
Approval Date:Jan 12, 2011TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength62.5MG;25MG
Approval Date:Apr 6, 2015TE:ABRLD:No

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