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01 1ALLERGAN

02 1BRECKENRIDGE

03 1APOTEX

04 1CHARTWELL RX

05 1EPIC PHARMA LLC

06 1SANDOZ

07 1SOMERSET THERAPS LLC

08 1SUN PHARM INDS

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PharmaCompass

01

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Antibody Engineering
Not Confirmed

EPINASTINE HYDROCHLORIDE

Brand Name : ELESTAT

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2003-10-16

Application Number : 21565

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Abbvie CB

02

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Antibody Engineering
Not Confirmed

EPINASTINE HYDROCHLORIDE

Brand Name : EPINASTINE HYDROCHLORIDE

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : 0.05%

Approval Date : 2011-03-14

Application Number : 90870

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Breckenridge Pharmaceutical

03

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

EPINASTINE HYDROCHLORIDE

Brand Name : EPINASTINE HYDROCHLORIDE

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : 0.05%

Approval Date : 2011-10-31

Application Number : 90919

RX/OTC/DISCN : RX

RLD : No

TE Code : AT

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04

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

EPINASTINE HYDROCHLORIDE

Brand Name : EPINASTINE HYDROCHLORIDE

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : 0.05%

Approval Date : 2016-12-07

Application Number : 203384

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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05

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

EPINASTINE HYDROCHLORIDE

Brand Name : EPINASTINE HYDROCHLORIDE

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : 0.05%

Approval Date : 2017-05-05

Application Number : 204055

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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06

Antibody Engineering
Not Confirmed
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07

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

EPINASTINE HYDROCHLORIDE

Brand Name : EPINASTINE HYDROCHLORIDE

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : 0.05%

Approval Date : 2011-10-31

Application Number : 90951

RX/OTC/DISCN : RX

RLD : No

TE Code : AT

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08

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

EPINASTINE HYDROCHLORIDE

Brand Name : EPINASTINE HYDROCHLORIDE

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : 0.05%

Approval Date : 2011-10-31

Application Number : 91626

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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