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01 62care4

02 3Adcock Ingram

03 2Alcon Inc

04 2Alfasigma

05 1Amman Pharmaceutical Industries

06 1Apotex Inc

07 1Appasamy Associates

08 4Bausch & Lomb Incorporated

09 1COOPER PHARMA

10 1Farmalider SA

11 4Farmigea

12 1Grup Farma

13 1Ha Noi CPC1 Pharmaceutical JSC

14 1Hanlim Pharmaceuticals Inc

15 5Horus Pharma

16 1Indiana Ophthalmics

17 1JAMP PHARMA

18 1Johnson & Johnson

19 12Laboratoires Thea

20 1Laboratorios Poen

21 2MS Pharma

22 3Novartis South Africa (Pty) Ltd

23 2Nutra Essential Otc Sl

24 4ORIFARM GROUP AS

25 3OmniVision

26 1Opes Health Care

27 1Pharma Stulln

28 1Raha Pharmaceutical Co

29 1S.F.GROUP Srl

30 2SIGMA TAU

31 2SO.SE.PHARM Srl

32 1Sandoz B2B

33 1Sentiss Pharma

34 1Seoul Pharma Co Ltd

35 1Sopharma

36 1Teva Pharmaceutical Industries

37 1Thea Pharma Sa

38 3Thea Sas Laboratories

39 1Unichem Pharmaceuticals USA, Inc

40 1Unimed Pharm Inc.

41 2Viatris

42 4World Medicine

43 2Xepa-Soul Pattinson m SDN BHD

44 1Zim Laboratories

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PharmaCompass

01

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Dosage Strength : EQ 0.025% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

ASPEN
Not Confirmed
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ASPEN
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

ASPEN
Not Confirmed
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ASPEN
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

ASPEN
Not Confirmed
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ASPEN
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

ASPEN
Not Confirmed
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ASPEN
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

ASPEN
Not Confirmed
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ASPEN
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 : DISCN

Registration Country : USA

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07

ASPEN
Not Confirmed
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ASPEN
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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08

ASPEN
Not Confirmed
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ASPEN
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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09

ASPEN
Not Confirmed
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ASPEN
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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10

ASPEN
Not Confirmed
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ASPEN
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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11

ASPEN
Not Confirmed
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ASPEN
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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12

ASPEN
Not Confirmed
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ASPEN
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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13

ASPEN
Not Confirmed
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ASPEN
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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14

ASPEN
Not Confirmed
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ASPEN
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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15

ASPEN
Not Confirmed
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ASPEN
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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16

ASPEN
Not Confirmed
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ASPEN
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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17

ASPEN
Not Confirmed
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ASPEN
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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18

ASPEN
Not Confirmed
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ASPEN
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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19

ASPEN
Not Confirmed
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ASPEN
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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20

ASPEN
Not Confirmed
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ASPEN
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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