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Arginine

Generic Name
Arginine
Brand Names
Aminosyn II 7 %, Sulfite-free, Aminosyn-PF 7%, Clinimix 2.75/5, Clinimix E 2.75/5, Clinisol 15, Freamine 6.9, Freamine III 10, Hepatamine 8, Olimel, Periolimel, Plenamine, Premasol, Primene, Procalamine 3, Prosol, R-gene, Travasol 10, Trophamine 10 %
Drug Type
Small Molecule
Chemical Formula
C6H14N4O2
CAS Number
74-79-3
Unique Ingredient Identifier
94ZLA3W45F

Overview

An essential amino acid that is physiologically active in the L-form.

Indication

Used for nutritional supplementation, also for treating dietary shortage or imbalance.

Associated Conditions

  • Acromegaly
  • Craniopharyngioma
  • Disorders of urea cycle metabolism
  • Gigantism
  • Hyperammonaemia
  • Hypophysectomy
  • Kidney Damage
  • Panhypopituitarism
  • Pituitary Dwarfism
  • Pituitary Neoplasms
  • Pituitary trauma
  • Problems of growth and stature

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2024/07/03
Not Applicable
Recruiting
General Hospital of Shenyang Military Region
2024/04/03
Phase 3
Not yet recruiting
2024/02/29
Phase 1
Recruiting
TJ Biopharma Co., Ltd.
2024/02/23
Phase 1
Recruiting
Armed Forces Institute of Dentistry, Pakistan
2023/10/06
Phase 4
Completed
Beijing Tiantan Hospital
2023/09/22
Not Applicable
Completed
Geropharm
2023/06/27
Not Applicable
Recruiting
University of Electronic Science and Technology of China
2023/05/11
Phase 2
Recruiting
2022/09/30
Phase 3
Completed
2022/06/30
Phase 4
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Baxter Healthcare Corporation
0338-0184
INTRAVENOUS
920 mg in 100 mL
4/13/2021
Baxter Healthcare Company
0338-0210
INTRAVENOUS
920 mg in 100 mL
9/21/2020
Baxter Healthcare Corporation
0338-0210
INTRAVENOUS
920 mg in 100 mL
9/21/2020
Baxter Healthcare Corporation
0338-1089
INTRAVENOUS
489 mg in 100 mL
4/13/2021
Baxter Healthcare Corporation
0338-1099
INTRAVENOUS
575 mg in 100 mL
4/13/2021
ICU Medical Inc.
0990-7171
INTRAVENOUS
1527 mg in 100 mL
5/4/2022
Baxter Healthcare Corporation
0338-0194
INTRAVENOUS
920 mg in 100 mL
4/13/2021
Baxter Healthcare Company
0338-1147
INTRAVENOUS
575 mg in 100 mL
9/21/2020
Baxter Healthcare Corporation
0338-1147
INTRAVENOUS
575 mg in 100 mL
9/21/2020
Baxter Healthcare Company
0338-1142
INTRAVENOUS
316 mg in 100 mL
9/21/2020

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
12.0g /1000ml
1/8/2013
SmofKabiven Electrolyte Free Emulsion for Infusion
SIN14292P
INJECTION, EMULSION
12.0g /1000ml
1/16/2013
NUTRIFLEX® OMEGA PLUS EMULSION FOR INFUSION
SIN15468P
INJECTION, EMULSION
2.592g/1000ml
4/23/2018
PERIOLIMEL N4E Emulsion for Infusion
SIN16888P
EMULSION
2.48g/L
10/20/2023
TROPHAMINE INJECTION 10%
SIN07846P
INJECTION
1.2 g/100 ml
9/12/1994
AMINOPLASMAL B.BRAUN 10% E SOLUTION FOR INFUSION
SIN15411P
INFUSION, SOLUTION
11.50g/1000ml
1/23/2018
SmofKabiven Peripheral Emulsion for Infusion
SIN14287P
INJECTION, EMULSION
12.0g /1000ml
1/8/2013
NUTRIFLEX® OMEGA SPECIAL B. BRAUN EMULSION FOR INFUSION
SIN16734P
INJECTION, EMULSION
3.780g/1000ml
3/7/2023
VAMINOLACT INTRAVENOUS SOLUTION
SIN07428P
INJECTION
4.1 g/1000 ml
5/12/1993
AMINOSTERIL N-HEPA FOR INTRAVENOUS INFUSION 8%
SIN10000P
INJECTION
10.72 g/l
9/15/1998

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Arginine Hydrochloride Tablets
国药准字H20057614
化学药品
片剂
11/15/2019
Arginine Hydrochloride Tablets
国药准字H11022102
化学药品
片剂
11/27/2020
Arginine Hydrochloride Tablets
国药准字H43021923
化学药品
片剂
11/6/2020
Arginine Hydrochloride for Injection
国药准字H20050685
化学药品
注射剂
6/24/2020
Arginine Hydrochloride for Injection
国药准字H20051875
化学药品
注射剂
9/2/2020
Arginine Hydrochloride for Injection
国药准字H20050686
化学药品
注射剂
6/24/2020
Arginine Hydrochloride for Injection
国药准字H20051876
化学药品
注射剂
9/2/2020
Arginine Hydrochloride for Injection
国药准字H20052504
化学药品
注射剂
3/9/2020
Arginine Hydrochloride for Injection
国药准字H20080593
化学药品
注射剂
12/7/2022
Arginine Hydrochloride Injection
国药准字H42023001
化学药品
注射剂
6/10/2022

PPB Drug Approvals

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