Quality Reevaluation

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Table Quality Reevaluation ( Nonproprietary name,Dosage Forms,Product Characteristics e.t.c.)

Notified No.
and full dates

22
2005/1/20

Therapeutic Category and

322
Classification

Mineral preparations

Nonproprietary name

Sodium Ferrous Citrate

Dosage Forms and

content

Tablets

50mg

Product Characteristics

Immediate-release

revolutions per minute

Paddle Method
50 rpm

Dissolution Medium

standardwater
others1.24.0 6.8

Dissolution Rate
(Dissolution Methods)

45minutes:Not less than 75%(UV method)

Ultraviolet-visible Spectrophotometry

Dissolution Profile

Sodium Ferrous Citrate

50mg

Table Product and Company

Standard
product

Brand Name

Company

Ferromia Tab. 50mg

Sannova Co., Ltd.

FENILENE Tab. 50mg

Kyowa Pharmaceutical Industry Co., Ltd.

FENELMIN Tab. 50mg

Kobayashi Kako Co.,Ltd.

FEROTYM Tab. 50

Sawai Pharmaceutical Co.,Ltd.

FEREDAIM Tab. 50mg

Taisho Pharmaceutical Industries, Ltd.

FERROSTEC Tab. 50mg

Teva Pharma Japan Inc

FOLIROMIN Tab. 50

Tsuruhara pharmaceutical Co.,Ltd.

IROMIA Tab.

Fuji Pharma Co., Ltd.

Ferrofeel Tab. 50mg

Fuso Pharmaceutical Industries,Ltd.

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19-09-2016 14:22