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01 1Actavis Inc
02 1Ajanta Pharma Limited
03 1Allrite Group
04 1Amneal Pharmaceuticals
05 1Ascent Innovative Medicines
06 1Lannett Company, Inc.
07 1MOUNTAIN
08 2Pfizer Inc
09 1Primus Pharmaceutical
10 1Rising Pharmaceuticals Inc
11 1Sandoz B2B
12 2ScieGen Pharmaceuticals
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01 12TABLET;ORAL
02 1Tablet
03 1XR Tablet
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01 5DISCN
02 7RX
03 2Blank
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01 10METAXALONE
02 2SKELAXIN
03 2Blank
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01 2India
02 12USA
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info :
Registration Country : India
Diclofenac Potassium; Metaxalone
Brand Name :
Dosage Form : Tablet
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : XR Tablet
Dosage Strength : 800MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : DISCN
Registration Country : USA
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Dosage Strength : 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info : DISCN
Registration Country : USA
Brand Name : METAXALONE
Dosage Form : TABLET;ORAL
Dosage Strength : 800MG
Packaging :
Approval Date : 2018-09-24
Application Number : 208774
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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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