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01 3ABBVIE
02 1TEVA PHARMS INC
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01 1CAPSULE;ORAL
02 1TABLET; FILM COATED
03 2TABLET;ORAL
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01 3RX
02 1Blank
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01 1ELAGOLIX
02 1ORIAHNN (COPACKAGED)
03 2ORILISSA
01 3Yes
02 1Blank
RLD : Yes
TE Code :
Brand Name : ORILISSA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 150MG BASE
Approval Date : 2018-07-23
Application Number : 210450
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : ORILISSA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 200MG BASE
Approval Date : 2018-07-23
Application Number : 210450
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
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
Approval Date : 2020-05-29
Application Number : 213388
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD :
TE Code :
Brand Name : ELAGOLIX
Dosage Form : TABLET; FILM COATED
Dosage Strength : 200MG
Approval Date :
Application Number : 217642
RX/OTC/DISCN :
RLD :
TE Code :