Tralement

Basic Information

Product Name

Tralement

FDA Product Code

0517-9305

Regulatory Information

NDC Product Code

0517-9305

Application Number

NDA209376

Marketing Category

C73594

Effective Date

July 7, 2020

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use TRALEMENT safely and effectively. See full prescribing information for TRALEMENT

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

ZINC SULFATE

Quantity: 3 mg in 1 mL

Code: 89DS0H96TB

Class Code: ACTIM

CUPRIC SULFATE

Quantity: 0.3 mg in 1 mL

Code: LRX7AJ16DT

Class Code: ACTIM

MANGANESE SULFATE

Quantity: 55 ug in 1 mL

Code: W00LYS4T26

Class Code: ACTIM

SELENIOUS ACID

Quantity: 60 ug in 1 mL

Code: F6A27P4Q4R

Class Code: ACTIB

WATER

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

CUPRIC CATION

Code: 8CBV67279L

SELENIOUS ACID

Code: F6A27P4Q4R

ZINC CATION

Code: 13S1S8SF37

MANGANESE CATION (2+)

Code: H6EP7W5457

Basic Information

Regulatory Information

Company Information

Active Ingredients

WATER

Active Moieties

CUPRIC CATION

SELENIOUS ACID

ZINC CATION

MANGANESE CATION (2+)