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01 1Apotex Inc
02 1MSN Laboratories
03 1Teva Pharmaceutical Industries
04 4Vanda Pharmaceuticals
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01 4CAPSULE;ORAL
02 1Capsule
03 2SUSPENSION;ORAL
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01 1Approved
02 5RX
03 1Blank
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01 1HETLIOZ
02 2HETLIOZ LQ
03 1Hetlioz
04 3TASIMELTEON
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01 1Sweden
02 6USA
Regulatory Info : RX
Registration Country : USA
Brand Name : TASIMELTEON
Dosage Form : CAPSULE;ORAL
Dosage Strength : 20MG
Packaging :
Approval Date : 2022-12-20
Application Number : 211607
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : TASIMELTEON
Dosage Form : CAPSULE;ORAL
Dosage Strength : 20MG
Packaging :
Approval Date : 2023-01-12
Application Number : 211654
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : TASIMELTEON
Dosage Form : CAPSULE;ORAL
Dosage Strength : 20MG
Packaging :
Approval Date : 2022-12-12
Application Number : 211601
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : HETLIOZ
Dosage Form : CAPSULE;ORAL
Dosage Strength : 20MG
Packaging :
Approval Date : 2014-01-31
Application Number : 205677
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : HETLIOZ LQ
Dosage Form : SUSPENSION;ORAL
Dosage Strength : 4MG/ML
Packaging :
Approval Date : 2020-12-01
Application Number : 214517
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : HETLIOZ LQ
Dosage Form : SUSPENSION;ORAL
Dosage Strength : 4MG/ML
Packaging :
Approval Date :
Application Number : 214517
Regulatory Info :
Registration Country : USA
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Hetlioz
Dosage Form : Capsule
Dosage Strength : 20mg
Packaging :
Approval Date : 03/07/2015
Application Number : 20140610000022
Regulatory Info : Approved
Registration Country : Sweden