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FDA Approval

Sterile Water

CompanyCivica, Inc. (DUNS: 081373942)

Effective Date

April 7, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Water(1 mL in 1 mL)

Registrants (1)

Hikma Pharmaceuticals USA Inc.

DUNS Number

946499746

Manufacturing Establishments (1)

Hikma Pharmaceuticals USA Inc.

Labeler

Civica, Inc.

Registrant

Hikma Pharmaceuticals USA Inc.

DUNS Number

946499746

Products (1)

Sterile Water

NDC Product Code

72572-747

Application Number

ANDA206369

Marketing Category

ANDA (C73584)

Route of Administration

INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

Effective Date

April 7, 2023

Ingredients

WaterActive

Code: 059QF0KO0RClass: ACTIBQuantity: 1 mL in 1 mL

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