Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 213388

ORIAHNN (COPACKAGED) (ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM)
EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE
Marketing Status: Prescription
Active Ingredient: ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM
Proprietary Name: ORIAHNN (COPACKAGED)
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213388
Product Number: 001
Approval Date: May 29, 2020
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
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