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01 5AbbVie Inc
02 1Assia Chemical Industries Ltd
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01 1CAPSULE;ORAL
02 2TABLET
03 1TABLET; FILM COATED
04 2TABLET;ORAL
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01 3RX
02 3Blank
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01 1ELAGOLIX
02 1ORIAHNN (COPACKAGED)
03 4ORILISSA
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01 2Canada
02 4USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ORILISSA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 150MG BASE
Packaging :
Approval Date : 2018-07-23
Application Number : 210450
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ORILISSA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 200MG BASE
Packaging :
Approval Date : 2018-07-23
Application Number : 210450
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM
Brand Name : ORIAHNN (COPACKAGED)
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE
Packaging :
Approval Date : 2020-05-29
Application Number : 213388
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Canada
Brand Name : ORILISSA
Dosage Form : TABLET
Dosage Strength : 150MG
Packaging : Jul-28
Approval Date :
Application Number : 2481332
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : ORILISSA
Dosage Form : TABLET
Dosage Strength : 200MG
Packaging : 14/56
Approval Date :
Application Number : 2481340
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : USA
Brand Name : ELAGOLIX
Dosage Form : TABLET; FILM COATED
Dosage Strength : 200MG
Packaging :
Approval Date :
Application Number : 217642
Regulatory Info :
Registration Country : USA