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ATOVAQUONE AND PROGUANIL HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GLENMARK PHARMS LTD · Approved 2011-01-12

Drug application

FDA Application #

ANDA091211

Application type

Abbreviated New Drug Application (Generic)

Brand name

ATOVAQUONE AND PROGUANIL HYDROCHLORIDE

Generic name

ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC

Active ingredients

ATOVAQUONE; PROGUANIL HYDROCHLORIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

GLENMARK PHARMS LTD

Manufacturer

Glenmark Pharmaceuticals Inc.,USA

First approval

2011-01-12

Source

Authoritative

Drugs@FDA application overview

Machine

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