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01 3Adcock Ingram

02 2Alcon Inc

03 1Alfasigma

04 1Amman Pharmaceutical Industries

05 1Apotex Inc

06 1Appasamy Associates

07 4Bausch & Lomb Incorporated

08 1Bayshore Pharmaceuticals

09 3Farmigea

10 1Grup Farma

11 1Ha Noi CPC1 Pharmaceutical JSC

12 1Hanlim Pharmaceuticals Inc

13 1Indiana Ophthalmics

14 1Johnson & Johnson

15 5Laboratoires Thea

16 1Laboratoires Théa S.A.S

17 1Laboratorios Poen

18 2MS Pharma

19 3Novartis South Africa (Pty) Ltd

20 1ORIFARM GROUP AS

21 2OmniVision

22 1Opes Health Care

23 1Raha Pharmaceutical Co

24 1S.F.GROUP Srl

25 2SIGMA TAU

26 2SO.SE.PHARM Srl

27 1Sentiss Pharma

28 1Seoul Pharma Co Ltd

29 1Teva Pharmaceutical Industries

30 1Thea Pharma

31 1Unimed Pharm Inc.

32 2Viatris

33 4World Medicine

34 2Xepa-Soul Pattinson m SDN BHD

35 1Zim Laboratories

36 2Blank

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PharmaCompass

01

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

KETOTIFEN FUMARATE

Brand Name : ZADITOR

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : EQ 0.025% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2006-10-19

Application Number : 21066

Regulatory Info : DISCN

Registration Country : USA

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02

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

KETOTIFEN FUMARATE

Brand Name : ZADITOR

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : EQ 0.025% BASE

Packaging :

Approval Date : 2008-09-02

Application Number : 77200

Regulatory Info : OTC

Registration Country : USA

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03

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

KETOTIFEN FUMARATE

Brand Name : KETOTIFEN FUMARATE

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : EQ 0.025% BASE

Packaging :

Approval Date : 2006-05-09

Application Number : 77354

Regulatory Info : OTC

Registration Country : USA

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04

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

KETOTIFEN FUMARATE

Brand Name : ALAWAY

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : EQ 0.025% BASE

Packaging :

Approval Date : 2006-12-01

Application Number : 21996

Regulatory Info : OTC

Registration Country : USA

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05

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

KETOTIFEN FUMARATE

Brand Name : CHILDRENS ALAWAY

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : EQ 0.025% BASE

Packaging :

Approval Date : 2015-02-11

Application Number : 21996

Regulatory Info : OTC

Registration Country : USA

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06

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

KETOTIFEN FUMARATE

Brand Name : ALAWAY

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : EQ 0.025% BASE

Packaging :

Approval Date : 2020-09-24

Application Number : 208158

Regulatory Info : OTC

Registration Country : USA

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07

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

KETOTIFEN FUMARATE

Brand Name : KETOTIFEN FUMARATE

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : EQ 0.025% BASE

Packaging :

Approval Date : 2020-06-01

Application Number : 204059

Regulatory Info : OTC

Registration Country : USA

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08

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

Ketotifen

Brand Name : Ketoftil

Dosage Form :

Dosage Strength : 25 Monod Coll 0.5 Ml 0.05%  

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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09

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

Ketotifen

Brand Name : FOTITEN M

Dosage Form : EYE DROP

Dosage Strength : 0.345MG/ML

Packaging : 5mL

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Korea

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10

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

KETOTIFEN FUMARATE

Brand Name : ACUVUE THERAVISION WITH KETOTIFEN

Dosage Form : DRUG-ELUTING CONTACT LENS;OPHTHALMIC

Dosage Strength : EQ 19MCG BASE

Packaging :

Approval Date : 2022-02-25

Application Number : 22388

Regulatory Info : DISCN

Registration Country : USA

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11

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

ketotifen hydrogen fumarate

Brand Name : Bentifen

Dosage Form : EYE DROPS, SOLUTION IN SINGLE-DOSE CONTAINERS

Dosage Strength : 0.25 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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12

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

ketotifen hydrogen fumarate

Brand Name : Bentifen

Dosage Form : EYE DROPS, SOLUTION

Dosage Strength : 0.25 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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13

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

ketotifen hydrogen fumarate

Brand Name : ZADITEN

Dosage Form : EYE DROPS, SOLUTION IN SINGLE-DOSE CONTAINERS

Dosage Strength : 0.25 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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14

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

ketotifen hydrogen fumarate

Brand Name : ZADITEN

Dosage Form : EYE DROPS, SOLUTION

Dosage Strength : 0.25 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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15

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

Ketotifen Fumarate

Brand Name :

Dosage Form : SYRUP

Dosage Strength : 1MG/5ML

Packaging : Pack Size in UPM - 120 ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Jordan

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16

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

Ketotifen Fumarate

Brand Name :

Dosage Form : TABLET

Dosage Strength : 1MG

Packaging : Pack Size in UPM - 1000 ,30

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Jordan

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17

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

KETOTIFEN FUMARATE

Brand Name : KETOTIFEN FUMARATE

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : EQ 0.025% BASE

Packaging :

Approval Date : 2007-07-26

Application Number : 77958

Regulatory Info : OTC

Registration Country : USA

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18

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

Ketotifen Fumarate

Brand Name : KETOTIFEN

Dosage Form : TABLET

Dosage Strength : 1.38MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Korea

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19

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

Ketotifen

Brand Name : Zaditen

Dosage Form : Ketotifen 2Mg 15 Units Oral Use

Dosage Strength : 15 CPR 2 mg prolonged release

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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20

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

Ketotifen

Brand Name : Zaditen

Dosage Form : Ketotifen 0,2Mg/Ml 200Ml Oral Use

Dosage Strength : 1 Bottle 200 ml 0.2 mg/ml syrup

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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21

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

Ketotifen Fumarate

Brand Name : Uniten

Dosage Form : OPTHALMIC SOLUTION

Dosage Strength : 0.69MG

Packaging : Blow Fill Seal System (BFS)

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Korea

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22

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

Ketotifen

Brand Name : Chetotifene

Dosage Form : Ketotifen 2Mg 15 Units Oral Use

Dosage Strength : 15 CPR 2 mg prolonged release

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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23

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

Ketotifen

Brand Name :

Dosage Form : ORAL DROPS

Dosage Strength : 1MG/ML

Packaging : 25 Ml/Bottle

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Turkey

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24

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

Ketotifen

Brand Name :

Dosage Form : EYE DROPS

Dosage Strength : 0.025%

Packaging : 5 Ml/Bottle

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Turkey

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25

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

Ketotifen

Brand Name : Asmafen

Dosage Form : SYRUP

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Malaysia

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26

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

Ketotifen

Brand Name : Asmafen

Dosage Form : TABLET

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Malaysia

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27

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

Ketotifen Fumarate

Brand Name :

Dosage Form : DC Granules and Tablets

Dosage Strength : 1MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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28

S.F.GROUP Srl

Country
Pharmtech & Ingredients
Not Confirmed
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S.F.GROUP Srl

Country
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Pharmtech & Ingredients
Not Confirmed

Ketotifen

Brand Name : Chetofen

Dosage Form : Ketotifen 2Mg 15 Units Oral Use

Dosage Strength : 15 CPR 2 mg prolonged release

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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29

SO.SE.PHARM Srl

Country
Pharmtech & Ingredients
Not Confirmed
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SO.SE.PHARM Srl

Country
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Pharmtech & Ingredients
Not Confirmed

Ketotifen

Brand Name : Sefen

Dosage Form : Ketotifen 2Mg/Ml 20Ml Oral Use

Dosage Strength : os gtt 20 ml 2 mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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30

SO.SE.PHARM Srl

Country
Pharmtech & Ingredients
Not Confirmed
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SO.SE.PHARM Srl

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Pharmtech & Ingredients
Not Confirmed

Ketotifen

Brand Name : Sefen

Dosage Form : Ketotifen 1Mg 40 Combined Oral Use

Dosage Strength : 40 cpr solub 1 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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