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Nicotinamide

Generic Name
Nicotinamide
Brand Names
Alertonic, Fortaplex, Infuvite, Infuvite Pediatric, Mvc-fluoride, Mvi Pediatric, Natafort, Neo-bex, Nicomide, Pregvit, Tandem Plus
Drug Type
Small Molecule
Chemical Formula
C6H6N2O
CAS Number
98-92-0
Unique Ingredient Identifier
25X51I8RD4

Overview

An important compound functioning as a component of the coenzyme NAD. Its primary significance is in the prevention and/or cure of blacktongue and pellagra. Most animals cannot manufacture this compound in amounts sufficient to prevent nutritional deficiency and it therefore must be supplemented through dietary intake.

Background

An important compound functioning as a component of the coenzyme NAD. Its primary significance is in the prevention and/or cure of blacktongue and pellagra. Most animals cannot manufacture this compound in amounts sufficient to prevent nutritional deficiency and it therefore must be supplemented through dietary intake.

Indication

用于防治糙皮病等烟酸缺乏病,也用于防治心脏传导阻滞。

Associated Conditions

  • Gastrointestinal insufficiency
  • Hepatic Insufficiency
  • Macrocytic anemia
  • Secondary anemia
  • Vitamin Deficiency
  • Severe debilitation

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/07/03
Not Applicable
Completed
Federal University of Rio Grande do Sul
2024/10/15
Phase 2
Recruiting
2024/09/19
Phase 2
Recruiting
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
2024/06/20
Phase 2
Recruiting
University of Chile
2024/02/28
Phase 1
Recruiting
2023/08/23
Phase 2
Recruiting
University Hospital, Angers
2023/07/24
Phase 3
Completed
KRL Hospital, Islamabad
2023/07/21
Phase 3
Recruiting
2023/01/27
Early Phase 1
Not yet recruiting
2022/08/24
Phase 3
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
AvPAK
50268-677
ORAL
20 mg in 1 1
4/12/2022
Sincerus Florida, LLC
72934-1017
TOPICAL
2 g in 100 g
4/23/2019
CarWin Pharmaceutical Associates, LLC
15370-105
ORAL
5 mg in 1 1
1/10/2024
Sincerus Florida, LLC
72934-2166
TOPICAL
4 g in 100 g
5/13/2019
Sincerus Florida, LLC
72934-1066
TOPICAL
4 g in 100 g
4/23/2019
Sincerus Florida, LLC
72934-1200
TOPICAL
4 g in 100 g
7/2/2020
Exeltis USA, Inc.
0642-7473
ORAL
15 mg in 1 1
2/14/2023
Marnel Pharmaceuticals, Inc.
0682-3001
ORAL
100 mg in 1 1
5/2/2014
Sincerus Florida, LLC
72934-5069
TOPICAL
4 g in 100 g
5/22/2019
Sincerus Florida, LLC
72934-1088
TOPICAL
5 g in 100 g
5/17/2019

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
ENZYPLEX TABLET
SIN06211P
ENTERIC COATED TABLET
10 mg
5/3/1991
CERNEVIT FOR INJECTION
SIN11975P
INJECTION, POWDER, FOR SOLUTION
46 mg/vial
6/5/2002
IBERET-FOLIC-500 TABLET
SIN05447P
TABLET, FILM COATED
30 mg
2/19/1991
TAMIPOOL FOR INJECTION
SIN11849P
INJECTION, POWDER, FOR SOLUTION
40 mg/vial
3/15/2002
SOLUVIT N FOR INFUSION
SIN05209P
INJECTION, POWDER, FOR SOLUTION
40 mg/vial
11/14/1990

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Nicotinamide Tablets
国药准字H44020174
化学药品
片剂
4/7/2020
Nicotinamide Tablets
国药准字H42020452
化学药品
片剂
7/13/2020
Nicotinamide Tablets
国药准字H35020747
化学药品
片剂
7/13/2020
Nicotinamide Tablets
国药准字H14022427
化学药品
片剂
9/9/2020
Nicotinamide Tablets
国药准字H20066794
化学药品
片剂
7/15/2020
Nicotinamide Tablets
国药准字H62020011
化学药品
片剂
4/10/2020
Nicotinamide Tablets
国药准字H14022428
化学药品
片剂
9/9/2020
Nicotinamide Tablets
国药准字H22022707
化学药品
片剂
3/11/2020
Nicotinamide Tablets
国药准字H41022869
化学药品
片剂
7/20/2020
Nicotinamide Tablets
国药准字H41021754
化学药品
片剂
5/6/2020

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
MULTIMAX SYRUP
N/A
N/A
N/A
7/8/2014
CERNEVIT FOR INJ
N/A
N/A
N/A
4/18/2008
BIOCATALIN INJECTABLE SOLN (VET)
N/A
N/A
N/A
8/9/1984
BIHAKU TAB
N/A
N/A
N/A
7/1/1994
HUAZIN INJ
N/A
N/A
N/A
4/28/1982

TGA Drug Approvals

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