Travasol

Basic Information

Product Name

Travasol

FDA Product Code

0338-0644

Regulatory Information

NDC Product Code

0338-0644

Application Number

NDA018931

Marketing Category

C73594

Effective Date

November 16, 2017

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . TRAVASOL (amino acids) injection, for intravenous useInitial U.S. Approval:

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

LEUCINE

Quantity: 730 mg in 100 mL

Code: GMW67QNF9C

Class Code: ACTIB

PHENYLALANINE

Quantity: 560 mg in 100 mL

Code: 47E5O17Y3R

Class Code: ACTIB

LYSINE HYDROCHLORIDE

Quantity: 580 mg in 100 mL

Code: JNJ23Q2COM

Class Code: ACTIM

METHIONINE

Quantity: 400 mg in 100 mL

Code: AE28F7PNPL

Class Code: ACTIB

ISOLEUCINE

Quantity: 600 mg in 100 mL

Code: 04Y7590D77

Class Code: ACTIB

VALINE

Quantity: 580 mg in 100 mL

Code: HG18B9YRS7

Class Code: ACTIB

HISTIDINE

Quantity: 480 mg in 100 mL

Code: 4QD397987E

Class Code: ACTIB

GLYCINE

Quantity: 1.03 g in 100 mL

Code: TE7660XO1C

Class Code: ACTIB

THREONINE

Quantity: 420 mg in 100 mL

Code: 2ZD004190S

Class Code: ACTIB

ALANINE

Quantity: 2.07 g in 100 mL

Code: OF5P57N2ZX

Class Code: ACTIB

ARGININE

Quantity: 1.15 g in 100 mL

Code: 94ZLA3W45F

Class Code: ACTIB

TRYPTOPHAN

Quantity: 180 mg in 100 mL

Code: 8DUH1N11BX

Class Code: ACTIB

PROLINE

Quantity: 680 mg in 100 mL

Code: 9DLQ4CIU6V

Class Code: ACTIB

TYROSINE

Quantity: 40 mg in 100 mL

Code: 42HK56048U

Class Code: ACTIB

SERINE

Quantity: 500 mg in 100 mL

Code: 452VLY9402

Class Code: ACTIB

ACETIC ACID

Code: Q40Q9N063P

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

METHIONINE

Code: AE28F7PNPL

LYSINE

Code: K3Z4F929H6

LEUCINE

Code: GMW67QNF9C

PHENYLALANINE

Code: 47E5O17Y3R

TRYPTOPHAN

Code: 8DUH1N11BX

GLYCINE

Code: TE7660XO1C

ISOLEUCINE

Code: 04Y7590D77

VALINE

Code: HG18B9YRS7

THREONINE

Code: 2ZD004190S

SERINE

Code: 452VLY9402

HISTIDINE

Code: 4QD397987E

ARGININE

Code: 94ZLA3W45F

PROLINE

Code: 9DLQ4CIU6V

TYROSINE

Code: 42HK56048U

ALANINE

Code: OF5P57N2ZX

Basic Information

Regulatory Information

Company Information

Active Ingredients

ACETIC ACID

WATER

Active Moieties

METHIONINE

LYSINE

LEUCINE

PHENYLALANINE

TRYPTOPHAN

GLYCINE

ISOLEUCINE

VALINE

THREONINE

SERINE

HISTIDINE

ARGININE

PROLINE

TYROSINE

ALANINE