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01 1ALCON PHARMA

02 1ALCON PHARMS LTD

03 1APOTEX INC

04 2BAUSCH AND LOMB

05 1BAUSCH AND LOMB INC

06 1BAYSHORE PHARMS LLC

07 1JOHNSON JOHNSON VISN

08 1SENTISS

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Dosage Strength : EQ 0.025% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2006-10-19

Application Number : 21066

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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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

Approval Date : 2008-09-02

Application Number : 77200

RX/OTC/DISCN : OTC

RLD : No

TE Code :

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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

Approval Date : 2006-05-09

Application Number : 77354

RX/OTC/DISCN : OTC

RLD : No

TE Code :

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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

Approval Date : 2006-12-01

Application Number : 21996

RX/OTC/DISCN : OTC

RLD : Yes

TE Code :

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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

Approval Date : 2015-02-11

Application Number : 21996

RX/OTC/DISCN : OTC

RLD : Yes

TE Code :

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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

Approval Date : 2020-09-24

Application Number : 208158

RX/OTC/DISCN : OTC

RLD : No

TE Code :

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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

Approval Date : 2020-06-01

Application Number : 204059

RX/OTC/DISCN : OTC

RLD : No

TE Code :

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08

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

Approval Date : 2022-02-25

Application Number : 22388

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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09

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

Approval Date : 2007-07-26

Application Number : 77958

RX/OTC/DISCN : OTC

RLD : No

TE Code :

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