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
01 12TABLET;ORAL
02 1XR Tablet
01 4DISCN
02 8RX
03 1Blank
01 10METAXALONE
02 2SKELAXIN
03 1Blank
01 1India
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 : 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Dosage Strength : 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Dosage Strength : 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Dosage Strength : 640MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 : RX
Registration Country : USA
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
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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