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01 1Brooks laboratories Limited

02 2Harrow

03 1Immedica Pharma

04 1JV Healthcare Limited

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PharmaCompass

01

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Fluorometholone Acetate

Brand Name :

Dosage Form : Eye/Ear Drop

Dosage Strength : 0.1% W/V

Packaging : Vial

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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02

AAPS
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AAPS
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FLUOROMETHOLONE ACETATE

Brand Name : FLAREX

Dosage Form : SUSPENSION/DROPS;OPHTHALMIC

Dosage Strength : 0.1%

Packaging :

Approval Date : 1986-02-11

Application Number : 19079

Regulatory Info : RX

Registration Country : USA

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03

AAPS
Not Confirmed
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AAPS
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FLUOROMETHOLONE ACETATE; TOBRAMYCIN

Brand Name : TOBRASONE

Dosage Form : SUSPENSION/DROPS;OPHTHALMIC

Dosage Strength : 0.1%;0.3%

Packaging :

Approval Date : 1989-07-21

Application Number : 50628

Regulatory Info : DISCN

Registration Country : USA

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04

AAPS
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AAPS
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Fluorometholone Acetate

Brand Name : Flarex

Dosage Form : Eye Drop Suspension

Dosage Strength : 1MG/ML

Packaging :

Approval Date : 2005-09-07

Application Number :

Regulatory Info : Withdrawn

Registration Country : Malta

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05

JV Healthcare Limited

Country
AAPS
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JV Healthcare Limited

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AAPS
Not Confirmed

Fluorometholone Acetate

Brand Name : Flarex,

Dosage Form : Eye Drop Suspension

Dosage Strength : 1MG/ML

Packaging :

Approval Date : 2025-05-05

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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