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ORIAHNN (COPACKAGED) (nda213388)- (EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE)

ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM ABBVIE
EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE
Yes Yes
2040-Aug-27 2023-Jul-23
None 2023-May-29
None No
ORIAHNN is a combination of elagolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist, estradiol, an estrogen, and norethindrone acetate, a progestin, indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.
0 0 0
Total Other Developers None
Drugs with Suitability No
EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE ** ** Up - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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