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FDA Approval

Qualaquin

CompanySun Pharmaceutical Industries, Inc. (DUNS: 146974886)

Effective Date

August 29, 2019

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Quinine(324 mg in 1 1)

Manufacturing Establishments (2)

Frontida BioPharm, Inc.

Labeler

Sun Pharmaceutical Industries, Inc.

DUNS Number

080243260

Labeler

Sun Pharmaceutical Industries, Inc.

DUNS Number

643611692

Products (1)

Qualaquin

NDC Product Code

49708-153

Application Number

NDA021799

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

August 29, 2019

Ingredients

Code: KF7Z0E0Q2BClass: ACTIBQuantity: 324 mg in 1 1

starch, cornInactive

Code: O8232NY3SJClass: IACT

magnesium stearateInactive

Code: 70097M6I30Class: IACT

talcInactive

Code: 7SEV7J4R1UClass: IACT

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