MedPath

Taurine

Generic Name
Taurine
Brand Names
Aminosyn-PF 7%, Premasol, Primene, Trophamine 10 %
Drug Type
Small Molecule
Chemical Formula
C2H7NO3S
CAS Number
107-35-7
Unique Ingredient Identifier
1EQV5MLY3D

Overview

Taurine, whose chemical name is 2-aminoethanesulfonic acid, is one of the most abundant amino acids in several organs. It plays important role in essential biological processes. This conditional amino acid can be either be manufactured by the body or obtained in the diet mainly by the consumption of fish and meat. The supplements containing taurine were FDA approved by 1984 and they are hypertonic injections composed by cristalline amino acids.

Indication

The use of diet supplements containing taurine is indicated for the nutritional support of infants and young pediatric patients requiring total parenteral nutrition via central or peripheral routes. The usage of diet supplements containing taurine prevents nitrogen and weight loss or to treat negative nitrogen balance in pediatric patients where the alimentary tract cannot be done through oral, gastrostomy or jejunostomy administration, there is impaired gastrointestinal absorption or protein requirements are substantially increased.

Associated Conditions

No associated conditions information available.

Clinical Trials

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Baxter Healthcare Corporation
0338-1131
INTRAVENOUS
15 mg in 100 mL
8/4/2022
B. Braun Medical Inc.
0264-1933
INTRAVENOUS
0.025 g in 100 mL
8/22/2022
ICU Medical Inc.
0990-4178
INTRAVENOUS
50 mg in 100 mL
9/21/2021
Baxter Healthcare Corporation
0338-1130
INTRAVENOUS
25 mg in 100 mL
8/4/2022
ICU Medical Inc.
0990-4179
INTRAVENOUS
70 mg in 100 mL
7/19/2022

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
SmofKabiven Emulsion for Infusion
SIN14286P
INJECTION, EMULSION
1.0g /1000ml
1/8/2013
SmofKabiven Electrolyte Free Emulsion for Infusion
SIN14292P
INJECTION, EMULSION
1.0g /1000ml
1/16/2013
TROPHAMINE INJECTION 10%
SIN07846P
INJECTION
0.025 g/100 ml
9/12/1994
SmofKabiven Peripheral Emulsion for Infusion
SIN14287P
INJECTION, EMULSION
1.0g /1000ml
1/8/2013
SMOFKABIVEN EXTRA NITROGEN ELECTROLYTE-FREE EMULSION FOR INFUSION
SIN16136P
INJECTION, EMULSION
0.65g/1000ml
3/24/2021
VAMINOLACT INTRAVENOUS SOLUTION
SIN07428P
INJECTION
300 mg/1000 ml
5/12/1993
AMINOVEN SOLUTION FOR INFUSION 15%
SIN16337P
INFUSION, SOLUTION
2g/L
9/30/2021
AMINOVEN SOLUTION FOR INFUSION 10%
SIN11829P
INJECTION
1.000 g/1000 ml
2/28/2002
PRIMENE 10% AMINO ACID INTRAVENOUS INFUSION
SIN10252P
INJECTION
0.6 g/l
9/23/1998
AMINOVEN SOLUTION FOR INFUSION 5%
SIN11682P
INJECTION
0.500 g/1000 ml
9/25/2001

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Taurine Capsules
国药准字H14022818
化学药品
胶囊剂
7/22/2020
Taurine Capsules
国药准字H41024646
化学药品
胶囊剂
7/23/2020
Taurine Capsules
国药准字H15021273
化学药品
胶囊剂
5/7/2020
Taurine Capsules
国药准字H23023079
化学药品
胶囊剂
5/13/2020
Taurine Capsules
国药准字H44024673
化学药品
胶囊剂
4/29/2020
Taurine Capsules
国药准字H14023097
化学药品
胶囊剂
12/29/2020
Taurine Capsules
国药准字H41024744
化学药品
胶囊剂
7/20/2020
Taurine Capsules
国药准字H23023054
化学药品
胶囊剂
3/30/2020
Taurine Capsules
国药准字H13023871
化学药品
胶囊剂
4/23/2020
Taurine Capsules
国药准字H61022629
化学药品
胶囊剂
11/20/2020

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
VAMINOLACT I.V. SOLUTION
N/A
N/A
N/A
10/14/1992

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