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FDA Approval

Sterile Water

CompanyNephron Pharmaceuticals Corporation (DUNS: 079160190)

Effective Date

June 4, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Water(1 mL in 1 mL)

Registrants (1)

Nephron SC Inc.

DUNS Number

079160190

Manufacturing Establishments (1)

Nephron SC Inc.

Labeler

Nephron Pharmaceuticals Corporation

Registrant

Nephron SC Inc.

DUNS Number

079160190

Products (1)

Sterile Water

NDC Product Code

0487-6105

Application Number

ANDA211222

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS

Effective Date

June 4, 2021

Ingredients

WaterActive

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

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