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ELAGOLIX

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HETERO LABS LIMITED · Approved 2025-07-01

Drug application

FDA Application #

ANDA217690

Application type

Abbreviated New Drug Application (Generic)

Brand name

ELAGOLIX

Generic name

Elagolix

Active ingredients

ELAGOLIX

Dosage form

TABLET

Route

—

Marketing status

None (Tentative Approval)

Sponsor

HETERO LABS LIMITED

First approval

2025-07-01

Source

Authoritative

Drugs@FDA application overview

Machine

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