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SHEUR

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: TEVA PHARM · Approved 2025-09-22

Drug application

FDA Application #
ANDA217650
Application type
Abbreviated New Drug Application (Generic)
Brand name
SHEUR
Generic name
Elagolix, Estradiol And Norethindrone Acetate And Elagolix
Active ingredients
ELAGOLIX, ESTRADIOL AND NORETHINDRONE ACETATE AND ELAGOLIX
Dosage form
CAPSULE
Route
—
Marketing status
Prescription
Sponsor
TEVA PHARM
First approval
2025-09-22

Source

Authoritative
Drugs@FDA application overview
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