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Last Updated: November 4, 2024

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 Pharms Ltd and Mylan 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. Ten suppliers are listed for this compound. Additional details are available on the atovaquone; proguanil hydrochloride profile page.
Summary for 091211
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 PD-Rx Pharmaceuticals, Inc. 43063-393 43063-393-14 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-393-14)
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE atovaquone; proguanil hydrochloride TABLET;ORAL 091211 ANDA PD-Rx Pharmaceuticals, Inc. 43063-393 43063-393-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (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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