Epinastine Hydrochloride | All | Licensing, EU CTD Dossiers, Formulation Suppliers

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U.S.A

Regulatory Info : Allowed

Registration Country : Switzerland

Epinastine Hydrochloride

Brand Name : Relestat

Dosage Form : Eye Drop

Dosage Strength : 0.5mg/ml

Packaging :

Approval Date : 07/12/2004

Application Number : 56310

Regulatory Info : Allowed

Registration Country : Switzerland

Portfolio PDF

Product Web Link

Corporate PDF

02

Allergan Aesthetics

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U.S.A

Regulatory Info : DISCN

Registration Country : USA

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Dosage Strength : 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2003-10-16

Application Number : 21565

Regulatory Info : DISCN

Registration Country : USA

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Product Web Link

Corporate PDF

03

AbbVie Inc

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U.S.A

Regulatory Info : Approved

Registration Country : Sweden

Epinastine Hydrochloride

Brand Name : Relestat

Dosage Form : Eye Drop

Dosage Strength : 0.5mg/ml

Packaging :

Approval Date : 18/10/2002

Application Number : 20021018000022

Regulatory Info : Approved

Registration Country : Sweden

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04

AbbVie Inc

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U.S.A

Regulatory Info : Originator

Registration Country : South Africa

Epinastine hydrochloride

Brand Name : Relestat

Dosage Form : OPD

Dosage Strength : 10mg/ml

Packaging : 5X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Product Web Link

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05

AbbVie Inc

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U.S.A

Regulatory Info : Authorized

Registration Country : Spain

Epinastin Hydrochloride

Brand Name : Relay

Dosage Form : Eye Drop Solution

Dosage Strength : 0.5MG

Packaging :

Approval Date : 2003-09-12

Application Number : 65574

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

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06

Allergan Aesthetics

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U.S.A

Regulatory Info :

Registration Country : Italy

Epinastine

Brand Name : Relestat

Dosage Form :

Dosage Strength : Coll 5 Ml 0,5 Mg/Ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

Portfolio PDF

Product Web Link

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07

Apotex Inc

Canada

PREP

Not Confirmed

08

Boehringer Ingelheim GmbH

Germany

PREP

Not Confirmed

09

Chartwell Pharmaceuticals llc

PREP

Not Confirmed

10

Epic Pharma. LLC.