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FDA Approval

QUININE SULFATE

CompanyIngenus Pharmaceuticals, LLC (DUNS: 833250017)

Effective Date

August 28, 2019

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Quinine(324 mg in 1 1)

Registrants (1)

Novast Laboratories , Ltd.

DUNS Number

527695995

Manufacturing Establishments (1)

Ingenus Pharmaceuticals NJ, LLC

Labeler

Ingenus Pharmaceuticals, LLC

Registrant

Novast Laboratories , Ltd.

DUNS Number

964680206

Products (1)

QUININE SULFATE

NDC Product Code

50742-238

Application Number

ANDA204372

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 28, 2019

Ingredients

Code: KF7Z0E0Q2BClass: ACTIBQuantity: 324 mg in 1 1

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

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