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01 2DICHLORPHENAMIDE
02 6GLUCAGON
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01 8XERIS
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01 1SOLUTION;INTRAVENOUS
02 5SOLUTION;SUBCUTANEOUS
03 2TABLET;ORAL
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01 20.5MG/0.1ML (0.5MG/0.1ML)
02 41MG/0.2ML (1MG/0.2ML)
03 150MG
04 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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01 8USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : DARANIDE
Dosage Strength : 50MG **Federal Registe...
Packaging :
Approval Date : 1982-01-01
Application Number : 11366
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : KEVEYIS
Dosage Strength : 50MG
Packaging :
Approval Date : 2015-08-07
Application Number : 11366
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : SOLUTION;SUBCUTANEOUS
Brand Name : GVOKE PFS
Dosage Strength : 0.5MG/0.1ML (0.5MG/0.1...
Packaging :
Approval Date : 2019-09-10
Application Number : 212097
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : SOLUTION;SUBCUTANEOUS
Brand Name : GVOKE PFS
Dosage Strength : 1MG/0.2ML (1MG/0.2ML)
Packaging :
Approval Date : 2019-09-10
Application Number : 212097
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : SOLUTION;SUBCUTANEOUS
Brand Name : GVOKE HYPOPEN
Dosage Strength : 0.5MG/0.1ML (0.5MG/0.1...
Packaging :
Approval Date : 2019-09-10
Application Number : 212097
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : SOLUTION;SUBCUTANEOUS
Brand Name : GVOKE HYPOPEN
Dosage Strength : 1MG/0.2ML (1MG/0.2ML)
Packaging :
Approval Date : 2019-09-10
Application Number : 212097
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : SOLUTION;SUBCUTANEOUS
Brand Name : GVOKE KIT
Dosage Strength : 1MG/0.2ML (1MG/0.2ML)
Packaging :
Approval Date : 2021-08-20
Application Number : 212097
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : SOLUTION;INTRAVENOUS
Brand Name : GVOKE VIALDX
Dosage Strength : 1MG/0.2ML (1MG/0.2ML)
Packaging :
Approval Date : 2025-03-14
Application Number : 212097
Regulatory Info : RX
Registration Country : USA