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FDA Approval

QUALAQUIN

CompanySTAT RX USA LLC (DUNS: 786036330)

Effective Date

March 18, 2010

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Quinine(324 mg in 1 1)

Manufacturing Establishments (1)

STAT RX USA LLC

Labeler

STAT RX USA LLC

DUNS Number

786036330

Products (1)

QUALAQUIN

NDC Product Code

16590-595

Application Number

NDA021799

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

March 18, 2010

Ingredients

Code: KF7Z0E0Q2BClass: ACTIBQuantity: 324 mg in 1 1

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