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Harvard Business School
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US Department of Justice
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Generated: April 22, 2018

DrugPatentWatch Database Preview

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 eight 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 sixteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the atovaquone; proguanil hydrochloride profile page.
Summary for 091211
Applicant:Glenmark Generics
Ingredient:atovaquone; proguanil hydrochloride
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 AND PROGUANIL HYDROCHLORIDE atovaquone; proguanil hydrochloride TABLET;ORAL 091211 ANDA Aidarex Pharmaceuticals LLC 33261-900 N 33261-900-01
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE atovaquone; proguanil hydrochloride TABLET;ORAL 091211 ANDA PD-Rx Pharmaceuticals, Inc. 43063-393 N 43063-393-20

Profile for product number 001

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

Profile for product number 002

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

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Fish and Richardson
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Chinese Patent Office

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