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Berberine

Generic Name
Berberine
Drug Type
Small Molecule
Chemical Formula
C20H18NO4
CAS Number
2086-83-1
Unique Ingredient Identifier
0I8Y3P32UF

Overview

An alkaloid from Hydrastis canadensis L., Berberidaceae. It is also found in many other plants. It is relatively toxic parenterally, but has been used orally for various parasitic and fungal infections and as antidiarrheal.

Background

An alkaloid from Hydrastis canadensis L., Berberidaceae. It is also found in many other plants. It is relatively toxic parenterally, but has been used orally for various parasitic and fungal infections and as antidiarrheal.

Indication

主要用于志贺菌属、霍乱弧菌等敏感病原菌所致的胃肠炎、细菌性痢疾等肠道感染。 外用用于治疗敏感细菌引起的宫颈糜烂。

Associated Conditions

No associated conditions information available.

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2021/04/26
Phase 3
UNKNOWN
2021/03/10
Phase 4
UNKNOWN
Jun Tao
2021/01/06
Phase 4
Completed
Xijing Hospital of Digestive Diseases
2021/01/06
Phase 4
Not yet recruiting
Second Xiangya Hospital of Central South University
2020/09/10
Phase 3
UNKNOWN
Tianjin Second People's Hospital
2020/07/21
Phase 4
Completed
2020/06/16
Phase 1
UNKNOWN
2019/06/03
Early Phase 1
Completed
Jin-Kui Yang
2019/04/10
Phase 2
UNKNOWN
2018/12/10
Phase 2
Completed

FDA Drug Approvals

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Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

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Status
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No EMA approvals found for this drug.

HSA Drug Approvals

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No HSA approvals found for this drug.

NMPA Drug Approvals

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Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Berberine Hydrochloride Tablets
国药准字H41022366
化学药品
片剂
5/14/2020
Berberine Hydrochloride Tablets
国药准字H53021263
化学药品
片剂
6/16/2020
Berberine Hydrochloride Tablets
国药准字H34022304
化学药品
片剂
2/22/2022
Berberine Hydrochloride Tablets
国药准字H53021063
化学药品
片剂
7/6/2020
Berberine Hydrochloride Tablets
国药准字H37020050
化学药品
片剂
4/17/2020
Berberine Hydrochloride Tablets
国药准字H34021115
化学药品
片剂
11/2/2021
Berberine Hydrochloride Tablets
国药准字H50020643
化学药品
片剂
9/23/2020
Berberine Hydrochloride Tablets
国药准字H42022799
化学药品
片剂
9/17/2021
Berberine Hydrochloride Tablets
国药准字H51020847
化学药品
片剂(糖衣片)
3/3/2021
Berberine Hydrochloride Tablets
国药准字H42021984
化学药品
片剂
7/16/2020

PPB Drug Approvals

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Company
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Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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Status
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No TGA approvals found for this drug.
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