Lacellate Solution - 1000

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

IT3 Medical LLC

DUNS: 079971231

Effective Date

February 23, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Sodium chloride(600 mg in 100 mL)

Lactic acid(310 mg in 100 mL)

Calcium chloride(20 mg in 100 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

70529-027

Application Number

NDA016682

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS

Effective Date

June 6, 2018

Ingredients

Code: 451W47IQ8XClass: ACTIBQuantity: 600 mg in 100 mL

Code: TU7HW0W0QTClass: ACTIBQuantity: 310 mg in 100 mL

Code: M4I0D6VV5MClass: ACTIBQuantity: 20 mg in 100 mL

Code: 660YQ98I10Class: ACTIMQuantity: 30 mg in 100 mL

WATERInactive

Code: 059QF0KO0RClass: IACT