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01 1Actavis Inc

02 1Ajanta Pharma Limited

03 1Amneal Pharmaceuticals

04 1Ascent Innovative Medicines

05 1Lannett Company, Inc.

06 1MOUNTAIN

07 2Pfizer Inc

08 1Primus Pharmaceutical

09 1Rising Pharmaceuticals Inc

10 1Sandoz B2B

11 2ScieGen Pharmaceuticals

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PharmaCompass

01

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

METAXALONE

Brand Name : METAXALONE

Dosage Form : TABLET;ORAL

Dosage Strength : 800MG

Packaging :

Approval Date : 2017-06-15

Application Number : 203695

Regulatory Info : RX

Registration Country : USA

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02

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

METAXALONE

Brand Name : METAXALONE

Dosage Form : TABLET;ORAL

Dosage Strength : 800MG

Packaging :

Approval Date : 2020-10-21

Application Number : 213836

Regulatory Info : DISCN

Registration Country : USA

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03

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

METAXALONE

Brand Name : METAXALONE

Dosage Form : TABLET;ORAL

Dosage Strength : 800MG

Packaging :

Approval Date : 2013-06-21

Application Number : 203399

Regulatory Info : RX

Registration Country : USA

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04

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

Metaxalone

Brand Name :

Dosage Form : XR Tablet

Dosage Strength : 800MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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05

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

METAXALONE

Brand Name : METAXALONE

Dosage Form : TABLET;ORAL

Dosage Strength : 800MG

Packaging :

Approval Date : 2016-11-22

Application Number : 204770

Regulatory Info : RX

Registration Country : USA

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06

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

METAXALONE

Brand Name : SKELAXIN

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1982-01-01

Application Number : 13217

Regulatory Info : DISCN

Registration Country : USA

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07

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

METAXALONE

Brand Name : SKELAXIN

Dosage Form : TABLET;ORAL

Dosage Strength : 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2002-08-30

Application Number : 13217

Regulatory Info : DISCN

Registration Country : USA

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08

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

METAXALONE

Brand Name : METAXALONE

Dosage Form : TABLET;ORAL

Dosage Strength : 640MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2015-06-01

Application Number : 22503

Regulatory Info : DISCN

Registration Country : USA

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09

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

METAXALONE

Brand Name : METAXALONE

Dosage Form : TABLET;ORAL

Dosage Strength : 800MG

Packaging :

Approval Date : 2018-09-24

Application Number : 208774

Regulatory Info : RX

Registration Country : USA

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10

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

METAXALONE

Brand Name : METAXALONE

Dosage Form : TABLET;ORAL

Dosage Strength : 800MG

Packaging :

Approval Date : 2010-03-31

Application Number : 40445

Regulatory Info : RX

Registration Country : USA

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11

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

METAXALONE

Brand Name : METAXALONE

Dosage Form : TABLET;ORAL

Dosage Strength : 800MG

Packaging :

Approval Date : 2017-08-31

Application Number : 207466

Regulatory Info : RX

Registration Country : USA

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12

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

METAXALONE

Brand Name : METAXALONE

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG

Packaging :

Approval Date : 2020-03-13

Application Number : 207466

Regulatory Info : RX

Registration Country : USA

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13

MOUNTAIN

Country
Fi Europe 2024
Not Confirmed
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MOUNTAIN

Country
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Fi Europe 2024
Not Confirmed

METAXALONE

Brand Name : METAXALONE

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG

Packaging :

Approval Date : 2015-02-27

Application Number : 40486

Regulatory Info : RX

Registration Country : USA

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