TIS-U-SOL

Basic Information

Product Name

TIS-U-SOL

FDA Product Code

0338-0190

Regulatory Information

NDC Product Code

0338-0190

Application Number

NDA018508

Marketing Category

C73594

Effective Date

February 21, 2014

Territorial Authority

USA

FDA Title

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Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

POTASSIUM CHLORIDE

Quantity: 40 mg in 100 mL

Code: 660YQ98I10

Class Code: ACTIB

POTASSIUM PHOSPHATE, MONOBASIC

Quantity: 6.25 mg in 100 mL

Code: 4J9FJ0HL51

Class Code: ACTIB

SODIUM CHLORIDE

Quantity: 800 mg in 100 mL

Code: 451W47IQ8X

Class Code: ACTIB

WATER

Code: 059QF0KO0R

Class Code: IACT

MAGNESIUM SULFATE HEPTAHYDRATE

Quantity: 20 mg in 100 mL

Code: SK47B8698T

Class Code: ACTIB

SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

Quantity: 8.75 mg in 100 mL

Code: 70WT22SF4B

Class Code: ACTIB

Active Moieties

MAGNESIUM CATION

Code: T6V3LHY838

CHLORIDE ION

Code: Q32ZN48698

PHOSPHATE ION

Code: NK08V8K8HR

POTASSIUM CATION

Code: 295O53K152

Basic Information

Regulatory Information

Company Information

Active Ingredients

WATER

Active Moieties

MAGNESIUM CATION

CHLORIDE ION

PHOSPHATE ION

POTASSIUM CATION