Elliotts B

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

FDA Approval Summary

Company

Lukare Medical, LLC

DUNS: 062862393

Effective Date

November 16, 2018

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Sodium bicarbonate(19 mg in 10 mL)

D-glucose(8 mg in 10 mL)

Sodium chloride(73 mg in 10 mL)

magnesium sulfate, unspecified(3 mg in 10 mL)

Calcium chloride(2 mg in 10 mL)

Phosphate ion(2 mg in 10 mL)

Potassium chloride(3 mg in 10 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Lukare Medical, LLC

DUNS Number

062862393

Products1

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

Elliotts B

Product Details

NDC Product Code

55792-007

Application Number

NDA020577

Marketing Category

NDA (C73594)

Route of Administration

INTRATHECAL

Effective Date

November 16, 2018

Ingredients

Sodium bicarbonateActive

Code: 8MDF5V39QOClass: ACTIBQuantity: 19 mg in 10 mL

D-glucoseActive

Code: 5SL0G7R0OKClass: ACTIBQuantity: 8 mg in 10 mL

Sodium chlorideActive

Code: 451W47IQ8XClass: ACTIBQuantity: 73 mg in 10 mL

magnesium sulfate, unspecifiedActive

Code: DE08037SABClass: ACTIBQuantity: 3 mg in 10 mL

Calcium chlorideActive

Code: M4I0D6VV5MClass: ACTIBQuantity: 2 mg in 10 mL

Phosphate ionActive

Code: SE337SVY37Class: ACTIBQuantity: 2 mg in 10 mL

WaterInactive

Code: 059QF0KO0RClass: IACTQuantity: 10 mL in 10 mL

Potassium chlorideActive

Code: 660YQ98I10Class: ACTIBQuantity: 3 mg in 10 mL

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Elliotts B

FDA Approval Summary

Registrants1

Products1

Elliotts B

Product Details