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01 1Aspen Pharmacare Holdings

02 1Baxter Healthcare South Africa (Pty) Ltd

03 1Bioglan

04 2Boehringer Ingelheim GmbH

05 10Colgate Palmolive

06 4Dentirol Medical Ab

07 1Esro Ag

08 3Fertin Pharma AS

09 82Fresenius SE & Co. KGaA

10 1Haleon

11 9Karo Pharma

12 4Meda Ab

13 1Mimer Medical

14 1Morningside Healthcare

15 1PHYTOPHARM KLEKA S.A

16 2Pharmaceutical Contractors

17 1SIT LABORATORIO FARMAC. Srl

18 1Unimedic Pharma Ab

19 4Viatris

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PharmaCompass

01

Sodium fluoride

Brand Name : Filibon

Dosage Form : CAP

Dosage Strength : 0.014u

Packaging : 30X1u

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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02

PackExpo
Not Confirmed
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SODIUM FLUORIDE; TRICLOSAN

Brand Name : COLGATE TOTAL

Dosage Form : PASTE;DENTAL

Dosage Strength : 0.24%;0.3%

Packaging :

Approval Date : 1997-07-11

Application Number : 20231

Regulatory Info : DISCN

Registration Country : USA

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03

PackExpo
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Sodium Fluoride

Brand Name : Duraphat

Dosage Form : Dent Alva Case, suspension

Dosage Strength : 22.6 mg/ml

Packaging : Tube

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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04

PackExpo
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Sodium Fluoride

Brand Name : Duraphat

Dosage Form : Dent Alva Case, suspension

Dosage Strength : 22.6 mg/ml

Packaging : Sylinderampulle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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05

PackExpo
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Sodium Fluoride

Brand Name : Duraphat

Dosage Form : Tooth Paste

Dosage Strength : 5 mg/g

Packaging : Tube

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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06

PackExpo
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Sodium fluoride

Brand Name : ITN 1606 N

Dosage Form : INF

Dosage Strength : 1ZZZ

Packaging : 1X1ZZZ

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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07

PackExpo
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Sodium fluoride

Brand Name : ITN 1502S

Dosage Form : INF

Dosage Strength : 1ZZZ

Packaging : 1X1ZZZ

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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08

PackExpo
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Sodium fluoride

Brand Name : ITN 1503 A

Dosage Form : INF

Dosage Strength : 1ZZZ

Packaging : 1X1ZZZ

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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09

PackExpo
Not Confirmed
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Sodium fluoride

Brand Name : ITN 1603 A

Dosage Form : INF

Dosage Strength : 1ZZZ

Packaging : 1X1ZZZ

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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10

PackExpo
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Sodium fluoride

Brand Name : ITN 3007 M

Dosage Form : INF

Dosage Strength : 1ZZZ

Packaging : 1X1ZZZ

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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11

PackExpo
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Sodium fluoride

Brand Name : ITN 7009 M

Dosage Form : INF

Dosage Strength : 1ZZZ

Packaging : 1X1ZZZ

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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12

PackExpo
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Sodium fluoride

Brand Name : ITN 7003 M

Dosage Form : INF

Dosage Strength : 1ZZZ

Packaging : 1X1ZZZ

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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13

PackExpo
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Sodium fluoride

Brand Name : ITN 1002 A *

Dosage Form : INF

Dosage Strength : 1ZZZ

Packaging : 1X1ZZZ

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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14

PackExpo
Not Confirmed
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Sodium fluoride

Brand Name : ITN 1003 A *

Dosage Form : INF

Dosage Strength : 1ZZZ

Packaging : 1X1ZZZ

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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15

PackExpo
Not Confirmed
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Sodium fluoride

Brand Name : ITN 2002 AD *

Dosage Form : INF

Dosage Strength : 1ZZZ

Packaging : 1X1ZZZ

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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16

PackExpo
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Sodium fluoride

Brand Name : ITN 3000 A

Dosage Form : INF

Dosage Strength : 1ZZZ

Packaging : 1X1ZZZ

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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17

PackExpo
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Sodium fluoride

Brand Name : ITN 3003 A

Dosage Form : INF

Dosage Strength : 1ZZZ

Packaging : 1X1ZZZ

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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18

PackExpo
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Oils, Peppermint; Thyme oil; Eucalyptus gobulus Labill; Salvia officinalis L.; Thymol; eucalyptol; Sodium Fluoride; Xylitol; Glycerol

Brand Name :

Dosage Form : Oral/Liquid

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Poland

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19

SIT LABORATORIO FARMAC. Srl

Country
PackExpo
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SIT LABORATORIO FARMAC. Srl

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Sodium Fluoride; Calcium Gluconate

Brand Name : Otofluor

Dosage Form :

Dosage Strength : 100 Cpr Gastrores 250 Mg + 10 Mg  

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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20

Baxter Healthcare South Africa (Pty...

Country
PackExpo
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Baxter Healthcare South Africa (Pty...

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Sodium fluoride

Brand Name : Nutryelt

Dosage Form : INF

Dosage Strength : 2099,5µg/10ml

Packaging : 10X10µg/10ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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